US FDA · 2024

Brands International CorporationMaterial and supplier control · Laboratory and QC controls · Equipment and facility · Quality unit oversight 2024-12-24 4 findings Sombra Cosmetics, Inc.Quality unit oversight · Laboratory and QC controls · Process validation · Material and supplier control 2024-12-24 4 findings Micro Orgo ChemTraining and personnel · Quality unit oversight · Laboratory and QC controls · Cleaning validation 2024-12-17 5 findings RC Outsourcing LLCComplaint and recall handling · Aseptic processing and sterility assurance · Process validation · Other quality system · Laboratory and QC controls · Material and supplier control 2024-12-12 8 findings TAILSTORM HEALTH INCAseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation · Labeling and packaging 2024-12-10 5 findings Zhejiang Uniquality Nursing Products Technology Co., Ltd. dba ZheJiang YouQuan Care Products Technology Co., Ltd.Material and supplier control · Quality unit oversight · Laboratory and QC controls 2024-12-03 3 findings LCC Ltd.Material and supplier control · Laboratory and QC controls · Quality unit oversight 2024-12-03 3 findings Patheon Italia S.p.A.Aseptic processing and sterility assurance · Equipment and facility · Stability and storage 2024-11-27 4 findings Hangzhou Huiji Biotechnology Co., Ltd.Quality unit oversight · Material and supplier control · Laboratory and QC controls 2024-11-26 3 findings Catwalk Cosmetic Laboratories Pty Ltd.Laboratory and QC controls · Process validation · Quality unit oversight · Stability and storage 2024-11-26 4 findings Regeneron Ireland Designated Activity CompanyLaboratory and QC controls · Other quality system · Deviation, CAPA, and investigation · Quality unit oversight · Equipment and facility 2024-11-22 6 findings OSRX Inc.Labeling and packaging · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight 2024-11-21 6 findings Frontier Biologics, LLCStability and storage · Aseptic processing and sterility assurance 2024-11-19 6 findings Colgate-Palmolive/Tom's of Maine, Inc.Equipment and facility · Complaint and recall handling 2024-11-19 3 findings Takeda Pharmaceutical Company, LimitedLaboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2024-11-15 4 findings Zhejiang Qimei Cosmetics Co., Ltd.Laboratory and QC controls · Material and supplier control · Aseptic processing and sterility assurance 2024-11-12 3 findings IntegraDose Compounding ServicesAseptic processing and sterility assurance · Regulatory reporting and change control · Quality unit oversight · Process validation · Contamination control · Deviation, CAPA, and investigation 2024-11-12 8 findings US Specialty FormulationsLaboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Material and supplier control · Other quality system · Quality unit oversight 2024-11-12 7 findings Multaler et Cie SASEquipment and facility · Material and supplier control · Laboratory and QC controls 2024-11-12 3 findings Staska Pharmaceuticals IncProcess validation · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Training and personnel · Regulatory reporting and change control · Quality unit oversight · Labeling and packaging 2024-11-05 9 findings Aarti Drugs LimitedOther quality system · Deviation, CAPA, and investigation · Quality unit oversight · Laboratory and QC controls · Equipment and facility 2024-11-01 7 findings Nephron Sterile Compounding CenterAseptic processing and sterility assurance · Deviation, CAPA, and investigation 2024-10-31 5 findings Mark Cuban Cost PlusEquipment and facility · Aseptic processing and sterility assurance · Quality unit oversight 2024-10-31 5 findings Jubilant HollisterStier General PartnershipOther quality system · Laboratory and QC controls · Aseptic processing and sterility assurance 2024-10-29 4 findings Novo NordiskEquipment and facility · Other quality system · Process validation · Quality unit oversight · Laboratory and QC controls 2024-10-29 8 findings MedOffice Saglik Endustri Anonim SirketiLaboratory and QC controls · Quality unit oversight · Material and supplier control 2024-10-29 3 findings Choice All Natural, Inc. dba Om BotanicalEquipment and facility · Laboratory and QC controls · Stability and storage 2024-10-29 3 findings Namita A. Goyal, M.D.Deviation, CAPA, and investigation · Training and personnel · Other quality system 2024-10-22 4 findings Soliteint Kozmetikai KFTLaboratory and QC controls · Process validation · Material and supplier control · Quality unit oversight 2024-10-22 4 findings Diora Kimya Sanayi ve Ticaret Limited SirketiMaterial and supplier control · Laboratory and QC controls · Cleaning validation 2024-10-22 3 findings Stokes Healthcare Inc. dba Epicur PharmaDocumentation and records · Aseptic processing and sterility assurance · Other quality system · Laboratory and QC controls · Equipment and facility · Quality unit oversight · Process validation · Deviation, CAPA, and investigation · Environmental monitoring 2024-10-22 27 findings Pinnacle Transplant Technologies, LLCAseptic processing and sterility assurance 2024-10-22 6 findings Amnio Technology, LLCOther quality system · Complaint and recall handling · Process validation 2024-10-22 3 findings Outin Futures Corp.Process validation · Quality unit oversight · Laboratory and QC controls · Computer system validation 2024-10-15 4 findings Hemarus LLCOther quality system · Material and supplier control 2024-10-15 4 findings Empower PharmacyAseptic processing and sterility assurance · Other quality system · Quality unit oversight · Laboratory and QC controls · Labeling and packaging · Deviation, CAPA, and investigation 2024-10-11 9 findings Nanchang Anobri Pharmaceutical Co., Ltd.Training and personnel · Other quality system · Equipment and facility · Documentation and records · Material and supplier control · Laboratory and QC controls · Process validation 2024-10-08 10 findings MMC Healthcare Ltd.Quality unit oversight · Laboratory and QC controls · Data integrity 2024-10-08 3 findings Apitoria Pharma Private Ltd.Equipment and facility · Other quality system · Quality unit oversight · Validation and qualification · Cleaning validation 2024-10-07 9 findings Qualgen LLCEquipment and facility · Quality unit oversight · Aseptic processing and sterility assurance · Labeling and packaging · Process validation · Training and personnel · Documentation and records · Complaint and recall handling 2024-10-07 12 findings BSO LLCTraining and personnel · Process validation · Aseptic processing and sterility assurance · Stability and storage 2024-10-02 4 findings Annovex Pharma, IncLabeling and packaging · Deviation, CAPA, and investigation · Other quality system · Regulatory reporting and change control · Aseptic processing and sterility assurance · Material and supplier control 2024-10-02 7 findings Little Moon Essentials, LLCDeviation, CAPA, and investigation · Laboratory and QC controls · Material and supplier control · Stability and storage · Process validation 2024-10-01 5 findings Clean Solutions LLCProcess validation · Complaint and recall handling · Material and supplier control · Laboratory and QC controls 2024-10-01 4 findings Diamond Chemical Co., Inc.Stability and storage · Process validation · Laboratory and QC controls 2024-10-01 3 findings Makra Kozmetika D.O.O.Quality unit oversight · Documentation and records · Material and supplier control · Laboratory and QC controls 2024-10-01 4 findings Fagron Compounding Services, LLCDeviation, CAPA, and investigation · Labeling and packaging · Quality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance · Complaint and recall handling 2024-09-26 7 findings ProRx LLCAseptic processing and sterility assurance · Quality unit oversight · Training and personnel · Stability and storage · Material and supplier control · Equipment and facility · Regulatory reporting and change control · Labeling and packaging · Deviation, CAPA, and investigation 2024-09-26 13 findings Takeda Pharmaceutical Company LimitedAseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Material and supplier control · Other quality system 2024-09-24 7 findings Aerosol and Liquid Packaging, Inc.Material and supplier control · Process validation · Equipment and facility · Quality unit oversight 2024-09-24 4 findings Wittman Pharma, Inc.Process validation · Material and supplier control · Quality unit oversight 2024-09-24 3 findings Hugel, Inc.Aseptic processing and sterility assurance · Equipment and facility · Environmental monitoring · Laboratory and QC controls 2024-09-23 4 findings First Cah Co., Ltd.Laboratory and QC controls · Material and supplier control · Stability and storage · Training and personnel · Quality unit oversight 2024-09-23 6 findings C&T Dream Co., Ltd.Material and supplier control · Equipment and facility · Laboratory and QC controls · Stability and storage · Process validation 2024-09-20 8 findings Mixlab TX LLCStability and storage · Aseptic processing and sterility assurance · Quality unit oversight · Laboratory and QC controls · Documentation and records 2024-09-19 7 findings Granules India Ltd.Quality unit oversight · Equipment and facility · Process validation · Deviation, CAPA, and investigation 2024-09-17 4 findings Gland Pharma Ltd.Aseptic processing and sterility assurance · Quality unit oversight 2024-09-17 3 findings Laboratorios Farmaceuticos Rovi S. A.Quality unit oversight · Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation 2024-09-17 4 findings Belcher Pharmaceuticals LLCRegulatory reporting and change control · Laboratory and QC controls · Labeling and packaging 2024-09-17 5 findings EnviroServe Chemicals & Cleaners Ltd.Quality unit oversight · Documentation and records · Stability and storage 2024-09-17 3 findings Aromas Para El Alma S.A.Documentation and records · Material and supplier control · Quality unit oversight 2024-09-17 4 findings Greco Gas, Inc.Laboratory and QC controls · Quality unit oversight · Equipment and facility · Deviation, CAPA, and investigation · Material and supplier control 2024-09-17 5 findings SSM Health Care St LouisDeviation, CAPA, and investigation · Equipment and facility · Stability and storage · Process validation · Labeling and packaging · Training and personnel · Aseptic processing and sterility assurance 2024-09-16 9 findings Zydus Lifesciences LimitedDeviation, CAPA, and investigation · Process validation · Aseptic processing and sterility assurance 2024-09-10 3 findings Orean Personal Care Ltd.Deviation, CAPA, and investigation · Process validation · Material and supplier control 2024-09-10 3 findings Taenaka Kogyo Co., Ltd.Equipment and facility · Other quality system · Validation and qualification 2024-09-06 4 findings Biocon Biologics LimitedData integrity · Stability and storage · Deviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance · Computer system validation 2024-09-06 8 findings Regenerative Processing Plant, LLCAseptic processing and sterility assurance · Complaint and recall handling · Stability and storage · Documentation and records · Laboratory and QC controls 2024-09-06 8 findings Kaylaan LLCEquipment and facility · Process validation · Material and supplier control · Laboratory and QC controls · Quality unit oversight 2024-09-03 5 findings Second Tokushima Factory, Otsuka Pharmaceutical Co. Ltd.Material and supplier control · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility 2024-08-30 5 findings Global Calcium Private LimitedOther quality system · Stability and storage · Equipment and facility · Documentation and records 2024-08-28 6 findings EyePoint Pharmaceuticals, Inc.Deviation, CAPA, and investigation · Process validation 2024-08-27 3 findings AnuMed International, LLCProcess validation · Material and supplier control · Laboratory and QC controls · Quality unit oversight 2024-08-27 4 findings Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.Process validation · Laboratory and QC controls · Aseptic processing and sterility assurance · Other quality system 2024-08-27 4 findings CARsgen Therapeutics CorporationDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Environmental monitoring · Process validation 2024-08-27 5 findings Eugia Pharma Specialities LimitedDocumentation and records · Aseptic processing and sterility assurance 2024-08-20 3 findings Central Admixture Pharmacy Services, Inc.Environmental monitoring · Aseptic processing and sterility assurance · Process validation · Deviation, CAPA, and investigation · Documentation and records · Quality unit oversight · Computer system validation · Equipment and facility · Data integrity · Laboratory and QC controls · Stability and storage 2024-08-13 29 findings Nowrez & Ismail Shukri CompanyStability and storage · Laboratory and QC controls · Material and supplier control 2024-08-13 3 findings Konrad Rejdak, M.D., Ph.D.Deviation, CAPA, and investigation 2024-08-13 3 findings LS Promotions Inc.Quality unit oversight · Stability and storage · Laboratory and QC controls 2024-08-13 4 findings Nubratori, IncAseptic processing and sterility assurance · Regulatory reporting and change control · Material and supplier control 2024-08-08 6 findings Imprimis NJOF, LLCDeviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance 2024-08-06 5 findings Olympia Compounding Pharmacy dba Olympia PharmacyComplaint and recall handling · Other quality system · Regulatory reporting and change control · Aseptic processing and sterility assurance · Process validation 2024-08-06 7 findings Omega Tech Labs LLCDeviation, CAPA, and investigation · Contamination control · Quality unit oversight · Material and supplier control · Stability and storage 2024-08-06 5 findings Carie Boyd PharmaceuticalsEquipment and facility · Aseptic processing and sterility assurance · Labeling and packaging 2024-07-26 5 findings Hikma Injectables USA Inc.Laboratory and QC controls · Aseptic processing and sterility assurance 2024-07-26 4 findings Brassica Pharma Pvt Ltd.Aseptic processing and sterility assurance · Equipment and facility · Process validation · Contamination control · Other quality system · Laboratory and QC controls 2024-07-25 9 findings Yahon Enterprise Co., Ltd.Stability and storage · Quality unit oversight · Material and supplier control · Laboratory and QC controls 2024-07-23 4 findings Brassica Pharma Pvt. Ltd.Aseptic processing and sterility assurance · Data integrity 2024-07-23 3 findings Genuine Virgin Aloe Corp dba TridermaProcess validation · Stability and storage · Documentation and records · Material and supplier control 2024-07-23 4 findings Biocon Biosphere LimitedLaboratory and QC controls · Quality unit oversight · Process validation 2024-07-16 3 findings Max Chemical Inc.Process validation · Material and supplier control · Quality unit oversight 2024-07-16 3 findings ARG Laboratories, Inc.Cleaning validation · Stability and storage · Material and supplier control 2024-07-16 3 findings YangZhou SuXiang Medical Instrument Co., Ltd.Material and supplier control · Process validation · Laboratory and QC controls 2024-07-16 3 findings Art of Beauty Company, Inc.Laboratory and QC controls · Deviation, CAPA, and investigation · Equipment and facility · Process validation · Material and supplier control 2024-07-16 5 findings Samsung BiologicsDeviation, CAPA, and investigation · Equipment and facility · Other quality system 2024-07-15 3 findings Denver Solutions LLC dba Leiters HealthLabeling and packaging · Stability and storage · Quality unit oversight · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility 2024-07-12 7 findings Hikma Pharmaceuticals USA Inc.Quality unit oversight · Laboratory and QC controls · Contamination control 2024-07-09 3 findings Optikem International Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight 2024-07-09 4 findings Laboratorio Magnachem InternationalDeviation, CAPA, and investigation · Computer system validation · Laboratory and QC controls 2024-07-09 3 findings New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye BankOther quality system 2024-07-09 3 findings Brookfield Medical Surgical SuppliesProcess validation · Aseptic processing and sterility assurance · Labeling and packaging 2024-06-28 3 findings Torrent Pharmaceuticals LimitedDeviation, CAPA, and investigation · Equipment and facility · Stability and storage 2024-06-26 3 findings Cipla LimitedLaboratory and QC controls · Aseptic processing and sterility assurance · Computer system validation · Material and supplier control · Quality unit oversight 2024-06-26 6 findings Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye BankOther quality system 2024-06-25 3 findings Dr. Reddy's Laboratories Limited CTO -- Unit 6Deviation, CAPA, and investigation · Quality unit oversight · Other quality system 2024-06-20 4 findings Aqualex Co., Ltd.Equipment and facility · Stability and storage · Laboratory and QC controls · Quality unit oversight · Process validation 2024-06-18 5 findings Landy InternationalMaterial and supplier control · Data integrity · Process validation · Laboratory and QC controls 2024-06-18 4 findings Neobiosis, LLCProcess validation · Stability and storage · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility 2024-06-18 9 findings GFA Production Xiamen Co., Ltd.Laboratory and QC controls · Process validation · Quality unit oversight 2024-06-18 3 findings Jubilant DraxImage Radiopharmacies Inc.Environmental monitoring · Aseptic processing and sterility assurance 2024-06-13 5 findings Fancystage Unipessoal, LDADocumentation and records · Process validation · Laboratory and QC controls 2024-06-11 3 findings TCT Nutraceuticals SDN. BHDStability and storage · Laboratory and QC controls · Material and supplier control 2024-06-11 3 findings Jiangsu Hengrui Pharmceuticals Co., LtdOther quality system · Quality unit oversight · Computer system validation · Contamination control · Equipment and facility · Aseptic processing and sterility assurance 2024-06-04 8 findings Safari Stem Cell, LLCLaboratory and QC controls · Complaint and recall handling · Cleaning validation · Aseptic processing and sterility assurance · Process validation · Deviation, CAPA, and investigation · Documentation and records 2024-05-28 8 findings Delta Pharma, Inc.Material and supplier control · Process validation 2024-05-21 3 findings Seatex, LLCEquipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Material and supplier control 2024-05-21 4 findings Central Admixture Pharmacy Services, Inc.Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage · Quality unit oversight · Computer system validation · Cleaning validation · Environmental monitoring · Regulatory reporting and change control · Equipment and facility · Other quality system 2024-05-21 17 findings Akan Biosciences, Inc.Other quality system · Process validation · Aseptic processing and sterility assurance 2024-05-21 8 findings Washington Fertility CenterOther quality system · Material and supplier control · Labeling and packaging · Deviation, CAPA, and investigation 2024-05-14 11 findings Vintage Chemical Inc.Material and supplier control · Laboratory and QC controls · Equipment and facility 2024-05-14 3 findings Grupo Quimico SRLComputer system validation · Quality unit oversight · Laboratory and QC controls 2024-05-14 3 findings Seatex, LLCQuality unit oversight · Equipment and facility · Deviation, CAPA, and investigation · Material and supplier control 2024-05-14 4 findings Westwood Laboratories LLCComplaint and recall handling · Material and supplier control · Laboratory and QC controls · Process validation 2024-05-14 4 findings Central Admixture Pharmacy Services, Inc.Laboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2024-05-14 4 findings Natuzen Co., Ltd.Material and supplier control · Quality unit oversight · Cleaning validation 2024-05-14 3 findings Eugia Pharma Specialities LimitedAseptic processing and sterility assurance · Contamination control · Other quality system · Deviation, CAPA, and investigation 2024-05-13 7 findings Global Cosmetics Company LimitedMaterial and supplier control · Stability and storage · Quality unit oversight 2024-05-07 3 findings Zydus Lifesciences Ltd.Laboratory and QC controls · Aseptic processing and sterility assurance · Training and personnel · Process validation · Equipment and facility · Deviation, CAPA, and investigation 2024-04-29 9 findings Northern VA Compounders PLLC, dba Akina PharmacyAseptic processing and sterility assurance · Other quality system 2024-04-23 9 findings Dr Sankunni’s Ayurvedic Research Foundation Private Ltd.Labeling and packaging · Other quality system 2024-04-23 12 findings Sun Pharmaceutical Industries LimitedDeviation, CAPA, and investigation · Equipment and facility · Complaint and recall handling · Quality unit oversight · Laboratory and QC controls 2024-04-17 6 findings Eugia Steriles Private LimitedProcess validation · Aseptic processing and sterility assurance · Other quality system 2024-04-16 3 findings Master Paints & Chemicals Corp.Quality unit oversight · Laboratory and QC controls · Material and supplier control 2024-04-16 3 findings C&T Dream Co., Ltd.Process validation · Material and supplier control · Equipment and facility 2024-04-16 3 findings Zydus Lifesciences LimitedAseptic processing and sterility assurance · Equipment and facility 2024-04-12 4 findings Cipla LimitedDeviation, CAPA, and investigation · Equipment and facility · Quality unit oversight 2024-04-10 4 findings FirstCham Co., Ltd.Quality unit oversight · Laboratory and QC controls · Process validation 2024-04-09 3 findings Antaria Pty. Ltd.Laboratory and QC controls · Stability and storage · Deviation, CAPA, and investigation 2024-04-09 4 findings Kilitch Healthcare India LimitedAseptic processing and sterility assurance · Quality unit oversight 2024-04-09 3 findings Jubilant Generics LimitedProcess validation · Deviation, CAPA, and investigation · Quality unit oversight 2024-04-05 4 findings Betone S.A. de C.V.Other quality system · Material and supplier control · Stability and storage · Laboratory and QC controls 2024-04-02 4 findings Bodywell Natural Skin Care Inc.Process validation · Material and supplier control · Documentation and records 2024-04-02 4 findings Deqing Jiarou Daily Chemical Co., Ltd.Material and supplier control · Laboratory and QC controls · Stability and storage · Quality unit oversight 2024-03-26 4 findings Higley Industries, Inc.Material and supplier control · Process validation · Quality unit oversight 2024-03-26 3 findings Catalent Indiana, LLCQuality unit oversight · Process validation · Laboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility 2024-03-22 6 findings Front Door Pharmacy, LLCAseptic processing and sterility assurance · Other quality system · Validation and qualification · Equipment and facility 2024-03-22 6 findings Stokes Healthcare Inc.Quality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance · Process validation · Labeling and packaging · Deviation, CAPA, and investigation 2024-03-22 9 findings Medi-Fare DrugMaterial and supplier control · Aseptic processing and sterility assurance · Labeling and packaging 2024-03-21 4 findings Sentara EnterprisesAseptic processing and sterility assurance · Other quality system 2024-03-20 5 findings Eugia SEZ Private LimitedEquipment and facility · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Training and personnel · Computer system validation · Process validation 2024-03-15 7 findings Cosmetic Specialty Labs, Inc.Quality unit oversight · Cleaning validation · Process validation · Material and supplier control 2024-03-05 4 findings Colgin, Inc.Quality unit oversight · Process validation · Material and supplier control 2024-03-05 3 findings Boothwyn Pharmacy LLCAseptic processing and sterility assurance · Training and personnel · Equipment and facility · Validation and qualification · Contamination control 2024-02-29 9 findings Amman Pharmaceutical IndustriesLaboratory and QC controls · Aseptic processing and sterility assurance · Quality unit oversight 2024-02-27 3 findings Eugia Pharma Specialities LimitedAseptic processing and sterility assurance · Process validation · Other quality system · Documentation and records · Computer system validation · Laboratory and QC controls · Deviation, CAPA, and investigation 2024-02-13 9 findings Ningbo Poplar Daily-UseLaboratory and QC controls · Stability and storage · Material and supplier control 2024-02-13 3 findings Wedgewood Connect, LLCAseptic processing and sterility assurance · Labeling and packaging · Deviation, CAPA, and investigation · Contamination control · Training and personnel · Quality unit oversight 2024-02-12 8 findings Empower Clinic Services LCC dba Empower PharmacyContamination control · Other quality system · Aseptic processing and sterility assurance · Environmental monitoring · Material and supplier control · Equipment and facility 2024-02-12 7 findings Sichuan Deebio Pharmaceutical Co. Ltd.Deviation, CAPA, and investigation · Equipment and facility · Process validation · Laboratory and QC controls · Other quality system 2024-02-08 5 findings Les Importations Herbasanté Inc.Quality unit oversight · Process validation · Material and supplier control 2024-02-06 3 findings AGC BiologicsComputer system validation · Other quality system · Quality unit oversight · Deviation, CAPA, and investigation 2024-01-31 4 findings Baxter Pharmaceuticals India Pvt Ltd.Documentation and records · Equipment and facility · Process validation · Aseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation 2024-01-30 8 findings Eugia US Manufacturing LLCAseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight · Material and supplier control · Other quality system · Equipment and facility · Computer system validation 2024-01-30 10 findings Central Admixture Pharmacy Services IncStability and storage · Documentation and records · Equipment and facility · Complaint and recall handling · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Process validation · Quality unit oversight 2024-01-25 14 findings Precision Equine LLCDeviation, CAPA, and investigation · Material and supplier control · Equipment and facility · Laboratory and QC controls · Quality unit oversight · Stability and storage 2024-01-25 7 findings Hybrid Pharma LLCOther quality system · Equipment and facility · Aseptic processing and sterility assurance · Documentation and records · Regulatory reporting and change control · Laboratory and QC controls 2024-01-25 11 findings Bausch & Lomb, Inc.Deviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance · Process validation 2024-01-17 4 findings Advanced Pharma Inc.Equipment and facility · Aseptic processing and sterility assurance · Laboratory and QC controls · Labeling and packaging 2024-01-17 5 findings Talon Compounding PharmacyAseptic processing and sterility assurance · Material and supplier control · Training and personnel · Process validation · Stability and storage 2024-01-17 10 findings Partners in Care Inc.Aseptic processing and sterility assurance · Stability and storage · Material and supplier control · Equipment and facility 2024-01-17 5 findings Alexander Infusion LLC dba Avanti Health Care ServicesStability and storage · Aseptic processing and sterility assurance 2024-01-17 6 findings Isomeric Pharmacy Solutions LLCTraining and personnel · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Labeling and packaging · Process validation · Equipment and facility · Stability and storage 2024-01-17 9 findings Hybrid Pharma LLCEquipment and facility · Aseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation · Stability and storage · Labeling and packaging · Training and personnel 2024-01-17 9 findings Alfred I. duPont Hospital for ChildrenAseptic processing and sterility assurance · Training and personnel 2024-01-17 5 findings Vital Care Compounder LLCStability and storage · Contamination control · Aseptic processing and sterility assurance · Process validation · Equipment and facility · Training and personnel 2024-01-17 11 findings University of Washington Medical Center Inpatient PharmacyStability and storage · Aseptic processing and sterility assurance · Training and personnel 2024-01-17 8 findings ImprimisRx Pharmacy, LLCProcess validation · Contamination control · Training and personnel · Equipment and facility · Quality unit oversight · Stability and storage 2024-01-17 8 findings US Compounding Inc.Quality unit oversight · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility 2024-01-17 5 findings Trone Health Services, Inc.Equipment and facility · Stability and storage · Aseptic processing and sterility assurance · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation 2024-01-17 6 findings William R. Grace M.D. P. C.Aseptic processing and sterility assurance 2024-01-17 4 findings Queens Express PharmacyAseptic processing and sterility assurance · Stability and storage · Training and personnel 2024-01-17 5 findings Stanley Specialty Pharmacy Compounding and Wellness CenterContamination control · Aseptic processing and sterility assurance 2024-01-17 4 findings Ballard Plaza Pharmacy I, Inc.Aseptic processing and sterility assurance · Training and personnel 2024-01-17 6 findings Option Care EnterprisesTraining and personnel · Aseptic processing and sterility assurance 2024-01-17 5 findings Premier Pharmacy Labs Inc.Contamination control · Aseptic processing and sterility assurance · Quality unit oversight · Labeling and packaging · Other quality system · Stability and storage · Material and supplier control · Equipment and facility 2024-01-17 9 findings Synergy Pharmacy ServicesAseptic processing and sterility assurance · Other quality system · Quality unit oversight · Laboratory and QC controls 2024-01-17 9 findings Sewaren Innovative Pharmaceutical Packaging dba SIPPAseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls 2024-01-17 3 findings University Of MichiganTraining and personnel · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2024-01-17 7 findings W & C dba The ApothecaryAseptic processing and sterility assurance · Quality unit oversight · Deviation, CAPA, and investigation · Stability and storage 2024-01-17 6 findings Jajco Inc. dba Anchor Drugs PharmacyDeviation, CAPA, and investigation · Stability and storage · Aseptic processing and sterility assurance · Equipment and facility 2024-01-17 6 findings Professional Partners Inc./ Westcliff Compounding PharmacyAseptic processing and sterility assurance · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls 2024-01-17 8 findings Town Total Compounding CenterTraining and personnel · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 6 findings Pharmakon Long Term Care Pharmacy Inc.Aseptic processing and sterility assurance · Quality unit oversight · Equipment and facility · Stability and storage · Training and personnel 2024-01-17 7 findings Precision Pharmacy Center LLCStability and storage · Aseptic processing and sterility assurance 2024-01-17 3 findings PharMEDium Services LLCLaboratory and QC controls · Aseptic processing and sterility assurance · Labeling and packaging · Quality unit oversight 2024-01-17 8 findings Ballard Plaza Pharmacy 1 Inc.Aseptic processing and sterility assurance · Training and personnel · Stability and storage 2024-01-17 7 findings Delta Pharma Inc.Training and personnel · Aseptic processing and sterility assurance · Equipment and facility · Laboratory and QC controls · Process validation · Labeling and packaging · Stability and storage · Documentation and records 2024-01-17 9 findings MedPark PharmacyAseptic processing and sterility assurance · Laboratory and QC controls 2024-01-17 5 findings Pharmakon Compounding Pharmacy Inc.Aseptic processing and sterility assurance · Equipment and facility · Stability and storage · Laboratory and QC controls · Training and personnel 2024-01-17 10 findings Kings Park Slope Inc.Training and personnel · Contamination control · Regulatory reporting and change control · Deviation, CAPA, and investigation · Labeling and packaging · Process validation · Aseptic processing and sterility assurance 2024-01-17 8 findings Region Care Inc. (Northwell Health)Aseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation · Equipment and facility 2024-01-17 8 findings Home Care Pharmacy of Palm Coast Inc.Training and personnel · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Documentation and records 2024-01-17 7 findings Algunas Inc. dba Woodland Hills Compounding PharmacyComplaint and recall handling · Equipment and facility · Deviation, CAPA, and investigation 2024-01-17 3 findings Pine Pharmacy and Home Care Products Center Inc.Training and personnel · Aseptic processing and sterility assurance · Stability and storage · Contamination control · Material and supplier control 2024-01-17 7 findings Well Care Discount Pharmacy LLC, dba Well Care Compounding PharmacyAseptic processing and sterility assurance · Equipment and facility · Stability and storage · Contamination control · Deviation, CAPA, and investigation 2024-01-17 11 findings Ranier’s Compounding LaboratoryAseptic processing and sterility assurance · Training and personnel · Stability and storage 2024-01-17 7 findings Arnold Professional PharmacyComputer system validation · Material and supplier control · Process validation · Laboratory and QC controls 2024-01-17 4 findings Baptist Health Medical Towers Pharmacy and Infusion ServicesTraining and personnel · Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation 2024-01-17 8 findings RX South DBA RX3 Compounding Pharmacy LLCContamination control · Stability and storage · Aseptic processing and sterility assurance 2024-01-17 4 findings RX South DBA RX3 Compounding Pharmacy LLCContamination control · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 5 findings Reliable Rexall-A Compounding PharmacyLabeling and packaging · Process validation · Deviation, CAPA, and investigation · Material and supplier control · Stability and storage · Other quality system 2024-01-17 7 findings Algunas Inc. dba Woodland Hills Compounding PharmacyEquipment and facility · Deviation, CAPA, and investigation · Complaint and recall handling 2024-01-17 3 findings Custom Meds Inc.Laboratory and QC controls 2024-01-17 3 findings Professional Arts PharmacyTraining and personnel · Aseptic processing and sterility assurance · Material and supplier control 2024-01-17 6 findings Catalent Pharma Solutions, LLCComputer system validation · Deviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility · Process validation · Other quality system · Quality unit oversight · Material and supplier control · Contamination control · Complaint and recall handling 2024-01-17 14 findings South Coast Specialty Compounding, Inc.Equipment and facility · Training and personnel · Aseptic processing and sterility assurance · Quality unit oversight · Contamination control 2024-01-17 7 findings Pharmakon Pharmaceuticals Inc.Training and personnel · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Quality unit oversight · Equipment and facility · Labeling and packaging · Laboratory and QC controls 2024-01-17 11 findings Meditech Laboratories, Inc.Aseptic processing and sterility assurance · Quality unit oversight · Deviation, CAPA, and investigation · Contamination control · Stability and storage · Laboratory and QC controls 2024-01-17 13 findings Colonia Care PharmacyLaboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 5 findings Pharmakon Pharmaceuticals Inc.Aseptic processing and sterility assurance · Training and personnel · Other quality system · Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Labeling and packaging 2024-01-17 14 findings Reliable Rexall-A Compounding PharmacyLaboratory and QC controls · Process validation · Material and supplier control · Labeling and packaging · Stability and storage · Deviation, CAPA, and investigation 2024-01-17 7 findings Walter’s PharmacyAseptic processing and sterility assurance · Material and supplier control · Contamination control · Stability and storage 2024-01-17 5 findings Medaus Inc.Process validation · Aseptic processing and sterility assurance · Stability and storage · Training and personnel · Equipment and facility 2024-01-17 9 findings Pacifico National Inc. dba Amex PharmacyComplaint and recall handling · Documentation and records · Aseptic processing and sterility assurance · Labeling and packaging · Stability and storage · Quality unit oversight · Other quality system 2024-01-17 9 findings PharMEDium Services LLCLaboratory and QC controls · Stability and storage · Aseptic processing and sterility assurance · Other quality system · Deviation, CAPA, and investigation 2024-01-17 6 findings RC Outsourcing LLCEquipment and facility · Aseptic processing and sterility assurance · Complaint and recall handling · Other quality system · Labeling and packaging 2024-01-17 7 findings RC Outsourcing LLCEquipment and facility · Labeling and packaging · Complaint and recall handling · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2024-01-17 8 findings Dignity Health- Northridge Hospital Medical CenterTraining and personnel · Aseptic processing and sterility assurance · Equipment and facility · Other quality system · Stability and storage 2024-01-17 8 findings I.V. Specialty Ltd.Aseptic processing and sterility assurance · Equipment and facility · Training and personnel · Deviation, CAPA, and investigation 2024-01-17 8 findings Anderson Holdings Inc.Training and personnel · Deviation, CAPA, and investigation · Laboratory and QC controls · Aseptic processing and sterility assurance 2024-01-17 7 findings Jeffreys Drug StoreEquipment and facility · Training and personnel · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 7 findings Wellcare Rx Investments LLC dba Denson’s Specialty PharmacyProcess validation · Stability and storage · Contamination control · Other quality system · Documentation and records · Material and supplier control · Aseptic processing and sterility assurance · Equipment and facility 2024-01-17 16 findings Weatherford Compounding Pharmacy LLCAseptic processing and sterility assurance 2024-01-17 5 findings QuVa Pharma, Inc.Aseptic processing and sterility assurance · Documentation and records 2024-01-17 4 findings QuVa Pharma, Inc.Aseptic processing and sterility assurance · Documentation and records · Material and supplier control 2024-01-17 5 findings Clark Professional Pharmacy, LLCAseptic processing and sterility assurance · Contamination control · Stability and storage 2024-01-17 7 findings Stonegate Pharmacy LPEquipment and facility · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Stability and storage · Laboratory and QC controls · Contamination control · Training and personnel 2024-01-17 12 findings Stonegate Pharmacy LPAseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation · Contamination control 2024-01-17 11 findings Auro Pharmacies, Inc.Aseptic processing and sterility assurance · Quality unit oversight · Deviation, CAPA, and investigation · Training and personnel · Laboratory and QC controls · Stability and storage 2024-01-17 9 findings Central Admixture Pharmacy Services Inc.Deviation, CAPA, and investigation · Documentation and records · Aseptic processing and sterility assurance · Equipment and facility 2024-01-17 7 findings Option Care Enterprises Inc.Contamination control · Aseptic processing and sterility assurance · Other quality system · Training and personnel 2024-01-17 6 findings JCB Laboratories LLCLaboratory and QC controls · Documentation and records · Material and supplier control · Aseptic processing and sterility assurance · Labeling and packaging 2024-01-17 5 findings Central Admixture Pharmacy Services Inc.Training and personnel · Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility 2024-01-17 5 findings Drug Depot Inc. dba APS PharmacyStability and storage · Contamination control · Material and supplier control · Aseptic processing and sterility assurance 2024-01-17 9 findings Carlton’s Dunwoody Pharmacy CorpQuality unit oversight · Stability and storage · Laboratory and QC controls · Documentation and records · Equipment and facility 2024-01-17 5 findings Stokes PharmacyOther quality system · Equipment and facility · Complaint and recall handling 2024-01-17 3 findings Dougherty's PharmacyAseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage · Training and personnel · Complaint and recall handling · Equipment and facility · Deviation, CAPA, and investigation 2024-01-17 12 findings Abbott's Compounding Pharmacy Inc.Aseptic processing and sterility assurance · Equipment and facility · Laboratory and QC controls · Contamination control 2024-01-17 10 findings Nebraska Methodist HospitalAseptic processing and sterility assurance · Laboratory and QC controls 2024-01-17 4 findings Jack P. Herick Inc. dba Glades DrugsMaterial and supplier control · Laboratory and QC controls 2024-01-17 4 findings Central Admixture Pharmacy Services, Inc.Aseptic processing and sterility assurance · Training and personnel 2024-01-17 3 findings Buderer Drug Company Inc.Aseptic processing and sterility assurance · Quality unit oversight · Equipment and facility 2024-01-17 5 findings Morton Drug Company dba Morton LTCContamination control · Aseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage 2024-01-17 7 findings University Rx Specialties Inc.Contamination control · Aseptic processing and sterility assurance · Laboratory and QC controls · Material and supplier control 2024-01-17 7 findings Elkhart PharmacyContamination control · Aseptic processing and sterility assurance 2024-01-17 3 findings Dorneyville PharmacyEquipment and facility · Stability and storage · Aseptic processing and sterility assurance · Training and personnel · Laboratory and QC controls · Quality unit oversight 2024-01-17 13 findings Wellcare Rx Investments LLC dba Denson’s Specialty PharmacyContamination control · Stability and storage · Process validation · Aseptic processing and sterility assurance · Equipment and facility · Material and supplier control · Laboratory and QC controls 2024-01-17 16 findings Empower Clinic Services LLCAseptic processing and sterility assurance · Stability and storage 2024-01-17 5 findings Jones Drug Company Inc. dba Reed’s Compounding PharmacyProcess validation · Training and personnel · Equipment and facility · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Documentation and records · Laboratory and QC controls · Contamination control 2024-01-17 15 findings Cape Apothecary Inc.Stability and storage · Training and personnel · Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation 2024-01-17 10 findings Jones Drug Company Inc. dba Reed’s Compounding PharmacyEquipment and facility · Documentation and records · Aseptic processing and sterility assurance · Training and personnel · Deviation, CAPA, and investigation · Computer system validation · Process validation · Laboratory and QC controls 2024-01-17 13 findings SaveWay Compounding Pharmacy Inc.Stability and storage · Training and personnel · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2024-01-17 7 findings Central Admixture Pharmacy Services Inc.Aseptic processing and sterility assurance · Equipment and facility · Training and personnel · Deviation, CAPA, and investigation · Material and supplier control 2024-01-17 9 findings American Pharmacy of Illinois Inc. dba Alwan’s PharmacyAseptic processing and sterility assurance · Training and personnel · Process validation · Contamination control · Equipment and facility · Laboratory and QC controls · Stability and storage 2024-01-17 13 findings American Pharmacy of Illinois Inc. dba Alwan’s PharmacyAseptic processing and sterility assurance · Stability and storage · Training and personnel · Contamination control · Equipment and facility · Process validation · Laboratory and QC controls 2024-01-17 14 findings INCELL Corporation LLCAseptic processing and sterility assurance · Labeling and packaging · Environmental monitoring 2024-01-17 4 findings American Family Pharmacy, LLCMaterial and supplier control · Quality unit oversight · Stability and storage · Laboratory and QC controls · Equipment and facility · Process validation · Documentation and records · Complaint and recall handling · Training and personnel 2024-01-17 14 findings RXQ Compounding LLCAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Labeling and packaging · Documentation and records · Training and personnel 2024-01-17 10 findings Coastal Meds, LLC.Training and personnel · Stability and storage · Regulatory reporting and change control · Aseptic processing and sterility assurance · Complaint and recall handling · Labeling and packaging 2024-01-17 8 findings AnazaoHealth CorporationContamination control · Aseptic processing and sterility assurance · Process validation · Other quality system · Environmental monitoring · Quality unit oversight · Material and supplier control 2024-01-17 14 findings Americare Compounding, LLCAseptic processing and sterility assurance · Training and personnel · Stability and storage · Contamination control 2024-01-17 7 findings Medistat RX, LLCAseptic processing and sterility assurance · Documentation and records · Labeling and packaging · Contamination control · Quality unit oversight · Deviation, CAPA, and investigation · Stability and storage 2024-01-17 11 findings Vann HealthcareAseptic processing and sterility assurance · Documentation and records · Contamination control · Material and supplier control 2024-01-17 4 findings Isomeric Pharmacy Solution, LLCAseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls 2024-01-17 4 findings RC Compounding Services, LLCAseptic processing and sterility assurance · Equipment and facility · Training and personnel 2024-01-17 8 findings IV Solutions of LubbockStability and storage · Other quality system · Aseptic processing and sterility assurance · Complaint and recall handling 2024-01-17 6 findings ApotheCure Inc.Documentation and records · Laboratory and QC controls · Material and supplier control · Aseptic processing and sterility assurance · Other quality system 2024-01-17 10 findings Prescription Lab Compounding PharmacyAseptic processing and sterility assurance 2024-01-17 3 findings Pacific Healthcare, Inc. dba B & B PharmacyEquipment and facility · Aseptic processing and sterility assurance · Documentation and records · Contamination control · Stability and storage · Laboratory and QC controls 2024-01-17 11 findings Bond Pharmacy Inc. dba Advanced Infusion SolutionsAseptic processing and sterility assurance 2024-01-17 5 findings Diabetes Corporation of AmericaProcess validation · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 8 findings Pharmaceutic Labs, LLC.Aseptic processing and sterility assurance · Training and personnel · Equipment and facility · Laboratory and QC controls · Stability and storage 2024-01-17 6 findings Pharmacy CreationsAseptic processing and sterility assurance · Stability and storage 2024-01-17 3 findings PharMEDium Services LLCAseptic processing and sterility assurance · Stability and storage 2024-01-17 5 findings Pine PharmaceuticalsRegulatory reporting and change control · Labeling and packaging · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls 2024-01-17 5 findings Pacific Healthcare, Inc. dba B & B PharmacyLaboratory and QC controls · Aseptic processing and sterility assurance · Documentation and records · Contamination control · Stability and storage · Equipment and facility 2024-01-17 10 findings Advanced Infusion SolutionsAseptic processing and sterility assurance · Contamination control 2024-01-17 4 findings PharMEDium Services, LLCAseptic processing and sterility assurance · Laboratory and QC controls · Documentation and records · Equipment and facility 2024-01-17 7 findings Medical Center Pharmacy, IncAseptic processing and sterility assurance · Equipment and facility · Stability and storage · Contamination control · Laboratory and QC controls · Training and personnel 2024-01-17 13 findings Downing Labs, LLCOther quality system · Equipment and facility · Process validation · Stability and storage · Labeling and packaging · Aseptic processing and sterility assurance · Laboratory and QC controls 2024-01-17 10 findings Qualgen LLCQuality unit oversight · Stability and storage · Documentation and records · Labeling and packaging · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Other quality system · Process validation · Contamination control · Training and personnel 2024-01-17 12 findings Sentara EnterprisesAseptic processing and sterility assurance · Equipment and facility · Stability and storage · Training and personnel · Deviation, CAPA, and investigation 2024-01-17 11 findings Chen Shwezin Inc. dba Park Compounding PharmacyAseptic processing and sterility assurance · Contamination control · Stability and storage · Equipment and facility 2024-01-17 9 findings Millers of Wyckoff, Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility · Material and supplier control · Training and personnel · Stability and storage · Quality unit oversight 2024-01-17 12 findings New England Home Therapies, Inc.Aseptic processing and sterility assurance · Contamination control · Laboratory and QC controls · Equipment and facility · Training and personnel 2024-01-17 7 findings PharMEDium Services, LLCOther quality system · Contamination control · Labeling and packaging · Laboratory and QC controls · Training and personnel · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Documentation and records 2024-01-17 9 findings US Compounding, Inc.Regulatory reporting and change control · Process validation · Aseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls · Labeling and packaging 2024-01-17 10 findings Bedford Pharmacy Inc.Laboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 6 findings People's Custom Rx and Clinical Care, LLCStability and storage · Laboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance 2024-01-17 9 findings JD & SN Inc., dba Moses Lake Professional PharmacyDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Documentation and records · Labeling and packaging · Stability and storage · Contamination control 2024-01-17 12 findings PharMEDium Services, LLC.Aseptic processing and sterility assurance · Stability and storage · Process validation · Labeling and packaging · Deviation, CAPA, and investigation · Laboratory and QC controls 2024-01-17 8 findings Eagle Pharmacy, Inc.Aseptic processing and sterility assurance · Regulatory reporting and change control · Contamination control · Laboratory and QC controls · Labeling and packaging · Stability and storage 2024-01-17 8 findings Hartley Medical Center Pharmacy, IncorporatedAseptic processing and sterility assurance · Training and personnel · Laboratory and QC controls 2024-01-17 6 findings Walgreens Home Care, Inc. dba Walgreens Infusion ServicesEquipment and facility · Stability and storage · Contamination control · Aseptic processing and sterility assurance 2024-01-17 6 findings The Compounding Pharmacy of AmericaAseptic processing and sterility assurance · Material and supplier control · Equipment and facility · Documentation and records · Process validation · Training and personnel · Stability and storage · Quality unit oversight 2024-01-17 16 findings Home Intensive Care Pharmacy, LLCEquipment and facility · Stability and storage · Training and personnel · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2024-01-17 8 findings Home Intensive Care Pharmacy, LLCTraining and personnel · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Stability and storage · Equipment and facility · Laboratory and QC controls 2024-01-17 8 findings Kalman Health & Wellness, Inc. dba Essential Wellness PharmaStability and storage · Equipment and facility · Laboratory and QC controls · Material and supplier control · Documentation and records · Aseptic processing and sterility assurance · Contamination control · Quality unit oversight 2024-01-17 15 findings Talon Compounding PharmacyTraining and personnel · Aseptic processing and sterility assurance · Stability and storage · Deviation, CAPA, and investigation · Material and supplier control 2024-01-17 10 findings Techni Med, Inc. dba The CompounderContamination control · Process validation · Laboratory and QC controls · Aseptic processing and sterility assurance · Material and supplier control · Stability and storage 2024-01-17 10 findings PCP LV LLC dba Pinnacle Compounding PharmacyAseptic processing and sterility assurance · Training and personnel · Quality unit oversight · Labeling and packaging · Stability and storage · Material and supplier control 2024-01-17 10 findings American Specialty PharmacyEquipment and facility · Aseptic processing and sterility assurance · Process validation · Contamination control · Training and personnel · Deviation, CAPA, and investigation 2024-01-17 10 findings Master Pharm LLCAseptic processing and sterility assurance · Contamination control 2024-01-17 6 findings Belmar PharmacyProcess validation · Laboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance 2024-01-17 5 findings PharMEDium Services, LLCAseptic processing and sterility assurance · Computer system validation · Laboratory and QC controls · Material and supplier control · Labeling and packaging · Equipment and facility 2024-01-17 11 findings Pharm D Solutions, LLC.Labeling and packaging · Aseptic processing and sterility assurance · Documentation and records 2024-01-17 8 findings Custom Compounding CenterContamination control · Aseptic processing and sterility assurance · Stability and storage · Material and supplier control 2024-01-17 6 findings Specialty Compounding LLC.Aseptic processing and sterility assurance 2024-01-17 8 findings Merissa Corp. dba Johnson Compounding and WellnessContamination control · Aseptic processing and sterility assurance · Training and personnel 2024-01-17 6 findings InfuScience a subsidiary of BioscripEquipment and facility · Stability and storage · Laboratory and QC controls · Complaint and recall handling · Training and personnel · Aseptic processing and sterility assurance · Contamination control 2024-01-17 10 findings Innovative Compounding PharmacyContamination control · Equipment and facility · Laboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 8 findings US Specialty Formulations LLC.Equipment and facility · Aseptic processing and sterility assurance · Process validation · Contamination control · Laboratory and QC controls 2024-01-17 9 findings Lincare, Inc.Equipment and facility · Aseptic processing and sterility assurance · Training and personnel 2024-01-17 5 findings Lincare, Inc.Aseptic processing and sterility assurance · Equipment and facility · Training and personnel 2024-01-17 5 findings The Wellness Center Pharmacy, Inc., dba Designer DrugsEquipment and facility · Aseptic processing and sterility assurance · Stability and storage · Material and supplier control · Laboratory and QC controls · Training and personnel 2024-01-17 13 findings College Pharmacy, Inc.Laboratory and QC controls · Aseptic processing and sterility assurance · Quality unit oversight · Training and personnel 2024-01-17 7 findings Montana Compounding Pharmacy and Wellness CenterEquipment and facility · Material and supplier control · Aseptic processing and sterility assurance · Documentation and records · Contamination control · Stability and storage 2024-01-17 11 findings Liberty Drug & SurgicalMaterial and supplier control · Aseptic processing and sterility assurance · Training and personnel · Laboratory and QC controls · Equipment and facility · Complaint and recall handling · Process validation 2024-01-17 13 findings Brookfield Medical / Surgical Supply, Inc.Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation · Process validation · Quality unit oversight · Documentation and records 2024-01-17 7 findings Brown’s Compounding Center, Inc.Laboratory and QC controls · Process validation · Aseptic processing and sterility assurance 2024-01-17 5 findings Tri-Med, Inc. dba Advanced Care Infusion-ShelbyDeviation, CAPA, and investigation · Stability and storage · Aseptic processing and sterility assurance · Training and personnel · Laboratory and QC controls · Quality unit oversight 2024-01-17 11 findings The Wellness Pharmacy, LLCEquipment and facility · Aseptic processing and sterility assurance · Contamination control 2024-01-17 4 findings Precision Pharmacy Center, LLCProcess validation · Stability and storage · Material and supplier control · Laboratory and QC controls 2024-01-17 5 findings Triangle CompoundingStability and storage · Aseptic processing and sterility assurance 2024-01-17 3 findings Tri-Med, Inc. dba Advanced Care Infusion-ShelbyOther quality system · Deviation, CAPA, and investigation · Stability and storage · Aseptic processing and sterility assurance · Equipment and facility 2024-01-17 14 findings Fallon Wellness Pharmacy, LLC.Stability and storage · Other quality system · Contamination control · Aseptic processing and sterility assurance · Material and supplier control 2024-01-17 8 findings Banner Pharmacy Services, LLCAseptic processing and sterility assurance · Equipment and facility · Contamination control · Documentation and records · Quality unit oversight · Deviation, CAPA, and investigation 2024-01-17 10 findings Health Innovations Pharmacy, IncMaterial and supplier control · Aseptic processing and sterility assurance · Process validation 2024-01-17 6 findings D.R. Pharmacy, Inc.Stability and storage · Laboratory and QC controls · Other quality system · Quality unit oversight · Process validation 2024-01-17 7 findings Burklow Pharmacy, Inc.Laboratory and QC controls 2024-01-17 3 findings The Apothecary Shoppe, LLCAseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls · Equipment and facility · Training and personnel 2024-01-17 10 findings Lato Drug Company, Inc. d.b.a. Post Haste PharmacyLaboratory and QC controls 2024-01-17 3 findings Physician Preferred Medical, LLCContamination control · Aseptic processing and sterility assurance · Equipment and facility · Training and personnel · Laboratory and QC controls · Deviation, CAPA, and investigation · Documentation and records · Stability and storage 2024-01-17 17 findings Ionia PharmacyLaboratory and QC controls · Aseptic processing and sterility assurance · Contamination control · Documentation and records · Stability and storage · Material and supplier control · Equipment and facility 2024-01-17 10 findings Right Value Drug Stores, Inc.Laboratory and QC controls · Documentation and records · Aseptic processing and sterility assurance · Equipment and facility · Material and supplier control · Training and personnel · Stability and storage 2024-01-17 12 findings Absolute Pharmacy, LLCProcess validation · Contamination control · Aseptic processing and sterility assurance · Documentation and records · Material and supplier control · Laboratory and QC controls 2024-01-17 11 findings Infusion Partners (subsidiary of BioScrip)Aseptic processing and sterility assurance · Training and personnel 2024-01-17 5 findings AnazaoHealth CorporationAseptic processing and sterility assurance · Regulatory reporting and change control · Labeling and packaging 2024-01-17 4 findings Advanced Physician Solutions, Inc.Contamination control · Equipment and facility · Laboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 9 findings Walgreens Infusion ServicesContamination control · Other quality system · Training and personnel · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 6 findings California Pharmacy & Compounding CenterDeviation, CAPA, and investigation · Labeling and packaging 2024-01-17 3 findings Summerton Drug Compounding and DispensaryEquipment and facility · Process validation · Material and supplier control · Stability and storage · Quality unit oversight 2024-01-17 6 findings Medistat RX L.L.C.Equipment and facility · Training and personnel · Process validation · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Complaint and recall handling · Laboratory and QC controls · Other quality system 2024-01-17 10 findings Stewart Compounding PharmacyTraining and personnel · Stability and storage · Equipment and facility · Other quality system · Contamination control · Laboratory and QC controls · Aseptic processing and sterility assurance 2024-01-17 9 findings Triad Isotopes Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Training and personnel · Quality unit oversight 2024-01-17 4 findings Triad Isotopes Inc.Training and personnel · Quality unit oversight · Aseptic processing and sterility assurance · Laboratory and QC controls 2024-01-17 4 findings Central Admixture Pharmacy Services, Inc.Training and personnel · Aseptic processing and sterility assurance · Documentation and records 2024-01-17 5 findings Unique Pharmaceutical, LtdContamination control · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Other quality system 2024-01-17 5 findings Jungle Jim’s PharmacyStability and storage · Aseptic processing and sterility assurance 2024-01-17 3 findings Pyramid Laboratories, Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation · Material and supplier control · Process validation · Equipment and facility · Quality unit oversight · Training and personnel 2024-01-17 13 findings Infusion Partners (subsidiary of BioScrip)Training and personnel · Aseptic processing and sterility assurance 2024-01-17 4 findings National Prescription Services Inc. dba HRI PharmacyEquipment and facility · Stability and storage · Process validation · Material and supplier control · Laboratory and QC controls 2024-01-17 5 findings Vann Healthcare Services IncAseptic processing and sterility assurance · Laboratory and QC controls · Training and personnel · Stability and storage 2024-01-17 7 findings Wood’s Pharmacy, Inc., dba The Medicine ShoppeStability and storage · Laboratory and QC controls · Equipment and facility · Process validation · Material and supplier control 2024-01-17 7 findings Jubilant HollisterStier, LLCComplaint and recall handling · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Documentation and records 2024-01-17 4 findings Spoonamore Drug Co Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage · Training and personnel 2024-01-17 7 findings Leiter’s CompoundingAseptic processing and sterility assurance · Quality unit oversight · Labeling and packaging · Material and supplier control 2024-01-17 4 findings Leiter’s CompoundingLabeling and packaging · Aseptic processing and sterility assurance · Quality unit oversight · Other quality system 2024-01-17 4 findings Diversified Pharmacy Inc dba University Compounding PharmacyQuality unit oversight · Aseptic processing and sterility assurance · Contamination control · Stability and storage · Equipment and facility 2024-01-17 8 findings Coastal Meds, LLC.Contamination control · Material and supplier control · Equipment and facility · Aseptic processing and sterility assurance 2024-01-17 4 findings Hieber’s PharmacyAseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage 2024-01-17 5 findings Total Pharmacy Services, IncStability and storage · Aseptic processing and sterility assurance · Training and personnel 2024-01-17 5 findings PharmaLogic CSP, Inc.Labeling and packaging · Stability and storage · Aseptic processing and sterility assurance · Quality unit oversight 2024-01-17 8 findings Northern New England Compounding Pharmacy, LLCLaboratory and QC controls · Aseptic processing and sterility assurance · Contamination control 2024-01-17 5 findings Marlborough HospitalAseptic processing and sterility assurance 2024-01-17 3 findings BioScrip Pharmacy (NY), Inc.Contamination control · Aseptic processing and sterility assurance · Stability and storage · Training and personnel · Laboratory and QC controls 2024-01-17 9 findings Infusion Systems of SW Florida Inc. dba Myerlee PharmacyAseptic processing and sterility assurance · Contamination control · Stability and storage · Material and supplier control · Other quality system 2024-01-17 9 findings Green Hills Health and Wellness Pharmacy IncEquipment and facility · Aseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls 2024-01-17 7 findings Triangle CompoundingLabeling and packaging · Aseptic processing and sterility assurance · Material and supplier control · Deviation, CAPA, and investigation 2024-01-17 5 findings Ambient Healthcare of Central Florida IncAseptic processing and sterility assurance · Contamination control · Stability and storage 2024-01-17 7 findings Wellness Pharmacy, IncAseptic processing and sterility assurance · Equipment and facility · Stability and storage · Laboratory and QC controls · Contamination control 2024-01-17 9 findings Oregon Compounding Centers, Inc., dba Creative CompoundsStability and storage · Laboratory and QC controls · Aseptic processing and sterility assurance · Training and personnel · Deviation, CAPA, and investigation 2024-01-17 10 findings South Coast Specialty Compounding, Inc. (Park Pharmacy and Compounding)Aseptic processing and sterility assurance · Stability and storage · Training and personnel 2024-01-17 7 findings HHCS Pharmacy, Inc. dba Freedom PharmacyLaboratory and QC controls · Training and personnel · Aseptic processing and sterility assurance 2024-01-17 8 findings Custom RX LLC, dba Custom RX Compounding PharmacyStability and storage · Material and supplier control · Laboratory and QC controls · Equipment and facility · Contamination control · Other quality system 2024-01-17 9 findings Complete Pharmacy & Medical Solutions, LLCAseptic processing and sterility assurance · Other quality system · Labeling and packaging 2024-01-17 12 findings Sina LLC, dba OncoMed (Onco 360)Aseptic processing and sterility assurance · Training and personnel · Equipment and facility · Laboratory and QC controls 2024-01-17 8 findings Perry DrugTraining and personnel · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 5 findings Nora Apothecary and Alternative Therapies, Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage 2024-01-17 6 findings Health Dimensions Inc.Laboratory and QC controls · Complaint and recall handling · Other quality system · Aseptic processing and sterility assurance 2024-01-17 5 findings DNA Pharmacy Services Inc dba Palm Beach CompoundingAseptic processing and sterility assurance · Stability and storage · Equipment and facility 2024-01-17 3 findings UCSF Home Therapy ServicesAseptic processing and sterility assurance · Process validation 2024-01-17 5 findings California Pharmacy & Compounding CenterDeviation, CAPA, and investigation · Labeling and packaging · Aseptic processing and sterility assurance · Laboratory and QC controls · Contamination control · Documentation and records · Training and personnel · Equipment and facility · Stability and storage 2024-01-17 15 findings Edge Pharmacy Sevices, LLCLabeling and packaging · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls 2024-01-17 6 findings Diamondback Drugs of Delaware, LLC,Aseptic processing and sterility assurance · Equipment and facility · Contamination control · Documentation and records · Stability and storage 2024-01-17 8 findings JHP Pharmaceuticals, Inc.Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation 2024-01-17 3 findings Custom Compounding CenterLaboratory and QC controls · Aseptic processing and sterility assurance 2024-01-17 3 findings Oregon Compounding Centers, Inc., dba Creative CompoundsAseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls · Training and personnel · Deviation, CAPA, and investigation 2024-01-17 10 findings Johnson Memorial Cancer CenterAseptic processing and sterility assurance · Contamination control 2024-01-17 5 findings Nebraska Methodist HospitalAseptic processing and sterility assurance · Training and personnel · Laboratory and QC controls 2024-01-17 6 findings Transdermal Therapeutics, IncComplaint and recall handling · Process validation · Equipment and facility · Material and supplier control · Laboratory and QC controls · Stability and storage · Labeling and packaging 2024-01-17 8 findings Wells Pharmacy Network LLCAseptic processing and sterility assurance · Other quality system · Quality unit oversight · Laboratory and QC controls · Stability and storage · Complaint and recall handling · Training and personnel · Documentation and records · Material and supplier control · Process validation 2024-01-17 21 findings Central Admixture Pharmacy Services, Inc.Other quality system · Training and personnel · Deviation, CAPA, and investigation · Equipment and facility · Labeling and packaging · Aseptic processing and sterility assurance · Stability and storage · Documentation and records · Contamination control · Laboratory and QC controls 2024-01-17 11 findings Martin Avenue Pharmacy, Inc.Aseptic processing and sterility assurance · Documentation and records · Stability and storage · Equipment and facility · Contamination control · Process validation · Material and supplier control · Laboratory and QC controls 2024-01-17 15 findings Central Admixture Pharmacy Services, Inc. (CAPS)Laboratory and QC controls · Training and personnel · Equipment and facility · Labeling and packaging · Aseptic processing and sterility assurance 2024-01-17 8 findings LeeSar, Inc.Aseptic processing and sterility assurance · Training and personnel · Quality unit oversight 2024-01-17 6 findings Central Admixture Pharmacy Services, Inc.Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation 2024-01-17 3 findings Downing Labs, LLC (formerly NuVision Pharmacy, Inc)Training and personnel · Other quality system · Quality unit oversight · Aseptic processing and sterility assurance · Material and supplier control · Stability and storage · Laboratory and QC controls · Equipment and facility 2024-01-17 13 findings Franck's Lab Inc dba Trinity Care SolutionsTraining and personnel · Contamination control · Aseptic processing and sterility assurance · Equipment and facility 2024-01-17 6 findings Jacobus Pharmaceutical Company, Inc.Equipment and facility · Laboratory and QC controls · Complaint and recall handling · Stability and storage · Contamination control · Computer system validation · Deviation, CAPA, and investigation · Process validation 2024-01-17 18 findings Central Admixture Pharmacy Services, Inc.Deviation, CAPA, and investigation · Other quality system · Material and supplier control · Equipment and facility · Laboratory and QC controls · Aseptic processing and sterility assurance · Contamination control 2024-01-17 10 findings Morton Grove Pharmaceuticals, Inc.Deviation, CAPA, and investigation · Stability and storage · Process validation · Quality unit oversight · Laboratory and QC controls · Equipment and facility · Training and personnel · Computer system validation 2024-01-17 12 findings One Way Drug, LLC dba Partell Specialty PharmacyContamination control · Laboratory and QC controls · Stability and storage · Aseptic processing and sterility assurance · Equipment and facility · Complaint and recall handling 2024-01-17 7 findings Healix Infusion Therapy, Inc.Training and personnel · Aseptic processing and sterility assurance 2024-01-17 3 findings Unique Pharmaceutical, LtdContamination control · Training and personnel · Aseptic processing and sterility assurance · Other quality system · Laboratory and QC controls · Labeling and packaging 2024-01-17 10 findings Infusion Options, Inc.Equipment and facility · Deviation, CAPA, and investigation · Contamination control · Other quality system · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls · Labeling and packaging 2024-01-17 12 findings Premier Pharmacy Labs, Inc.Aseptic processing and sterility assurance · Stability and storage · Contamination control · Deviation, CAPA, and investigation · Laboratory and QC controls · Documentation and records · Labeling and packaging · Equipment and facility 2024-01-17 15 findings Unique Pharmaceutical, LtdLaboratory and QC controls · Aseptic processing and sterility assurance · Training and personnel · Labeling and packaging · Contamination control · Other quality system 2024-01-17 10 findings SCA Pharmaceuticals, LLCAseptic processing and sterility assurance · Training and personnel · Deviation, CAPA, and investigation · Laboratory and QC controls · Labeling and packaging 2024-01-17 7 findings Pharmakon PharmaceuticalsDocumentation and records · Deviation, CAPA, and investigation · Process validation 2024-01-17 4 findings RX South LLC DBA RX3 PharmacyAseptic processing and sterility assurance · Quality unit oversight · Laboratory and QC controls · Other quality system · Equipment and facility · Process validation · Training and personnel 2024-01-17 11 findings US Compounding Inc.Laboratory and QC controls · Aseptic processing and sterility assurance · Labeling and packaging · Equipment and facility · Contamination control 2024-01-17 8 findings John W. Hollis Inc dba John Hollis PharmacyAseptic processing and sterility assurance · Stability and storage · Other quality system · Laboratory and QC controls · Equipment and facility · Material and supplier control 2024-01-17 10 findings Kings Park Slope, Inc.Aseptic processing and sterility assurance · Other quality system · Equipment and facility · Training and personnel 2024-01-17 8 findings KRS Global Biotechnology, IncAseptic processing and sterility assurance · Laboratory and QC controls · Training and personnel 2024-01-17 4 findings Region Care, Inc.,Aseptic processing and sterility assurance · Labeling and packaging · Material and supplier control 2024-01-17 4 findings Pharmakon Pharmaceuticals, Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility · Labeling and packaging · Training and personnel 2024-01-17 11 findings Pharmacia and Upjohn Company, LLCOther quality system · Process validation · Documentation and records 2024-01-17 6 findings Zions RX Formulations Services LLC dba Rx Formulation Serv.Contamination control · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Stability and storage · Equipment and facility 2024-01-17 8 findings Eastern Pharmacy, Inc.Documentation and records · Aseptic processing and sterility assurance · Stability and storage · Training and personnel 2024-01-17 6 findings Stewart Compounding PharmacyTraining and personnel · Aseptic processing and sterility assurance 2024-01-17 3 findings Leiter's Cambrian Park Drugs, Inc.Laboratory and QC controls · Stability and storage · Process validation · Documentation and records · Material and supplier control · Other quality system · Aseptic processing and sterility assurance 2024-01-17 9 findings Wells Pharmacy Network LLCOther quality system · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Training and personnel · Equipment and facility · Complaint and recall handling · Stability and storage · Laboratory and QC controls 2024-01-17 13 findings Greer Laboratories, Inc.Other quality system · Deviation, CAPA, and investigation · Laboratory and QC controls · Material and supplier control · Aseptic processing and sterility assurance 2024-01-17 8 findings Allergy Laboratories, Inc.Environmental monitoring · Training and personnel · Regulatory reporting and change control · Aseptic processing and sterility assurance · Other quality system · Contamination control · Deviation, CAPA, and investigation · Material and supplier control · Stability and storage · Cleaning validation · Labeling and packaging · Equipment and facility · Validation and qualification 2024-01-17 24 findings Nature's Pharmacy & Compounding CenterQuality unit oversight · Training and personnel · Aseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage · Equipment and facility 2024-01-17 9 findings Clinical ApothecariesLaboratory and QC controls · Aseptic processing and sterility assurance · Training and personnel · Stability and storage · Material and supplier control 2024-01-17 8 findings Meridian Medical Technologies a Pfizer CompanyProcess validation · Deviation, CAPA, and investigation · Quality unit oversight · Complaint and recall handling · Documentation and records · Aseptic processing and sterility assurance 2024-01-17 6 findings Jacobus Pharmaceutical Company, IncOther quality system · Equipment and facility · Laboratory and QC controls · Material and supplier control 2024-01-17 6 findings Meridian Medical Technologies, Inc.Laboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight · Other quality system · Training and personnel · Stability and storage · Material and supplier control · Complaint and recall handling · Labeling and packaging 2024-01-17 10 findings Pine Pharmacy and Home Care Products Center, IncAseptic processing and sterility assurance · Contamination control · Laboratory and QC controls · Equipment and facility · Training and personnel · Stability and storage 2024-01-17 9 findings Brookfield Prescription Center dba MD Custom RxAseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls · Complaint and recall handling · Material and supplier control 2024-01-17 6 findings Abrams Royal PharmacyEquipment and facility · Aseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight · Stability and storage · Documentation and records · Contamination control · Complaint and recall handling 2024-01-17 12 findings Cantrell Drug CompanyOther quality system · Training and personnel · Complaint and recall handling · Laboratory and QC controls · Material and supplier control · Aseptic processing and sterility assurance · Equipment and facility · Stability and storage · Quality unit oversight 2024-01-17 11 findings Specialty Medicine Compounding Pharmacy, P.C.Equipment and facility · Laboratory and QC controls · Process validation · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 5 findings Leiter's Cambrian Park Drugs, Inc.Equipment and facility · Quality unit oversight · Aseptic processing and sterility assurance · Contamination control · Process validation · Deviation, CAPA, and investigation · Documentation and records 2024-01-17 15 findings Wiley Chemists, Inc.Equipment and facility · Material and supplier control · Complaint and recall handling · Laboratory and QC controls · Process validation 2024-01-17 5 findings Delta Pharma, Inc.Aseptic processing and sterility assurance · Equipment and facility · Material and supplier control · Training and personnel 2024-01-17 8 findings Blue Ridge Pharmacy and Compounding CenterStability and storage · Aseptic processing and sterility assurance · Process validation · Training and personnel · Deviation, CAPA, and investigation 2024-01-17 9 findings Pharmagen Laboratories, IncContamination control · Training and personnel · Deviation, CAPA, and investigation · Documentation and records · Equipment and facility · Complaint and recall handling · Aseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage 2024-01-17 13 findings Pharmagen Laboratories, IncDeviation, CAPA, and investigation · Contamination control · Training and personnel · Other quality system · Equipment and facility · Aseptic processing and sterility assurance · Quality unit oversight · Complaint and recall handling · Stability and storage · Laboratory and QC controls · Documentation and records 2024-01-17 13 findings The Compounding Shop, Inc.Laboratory and QC controls · Stability and storage · Complaint and recall handling · Deviation, CAPA, and investigation 2024-01-17 4 findings Grandpa's Compounding Pharmacy, Inc.Laboratory and QC controls · Computer system validation · Equipment and facility · Training and personnel · Aseptic processing and sterility assurance 2024-01-17 9 findings Specialty Compounding, LLCDocumentation and records · Stability and storage · Complaint and recall handling · Laboratory and QC controls · Material and supplier control · Process validation · Equipment and facility · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight · Training and personnel 2024-01-17 14 findings Front Range Laboratories, IncorporatedContamination control · Training and personnel · Laboratory and QC controls · Quality unit oversight 2024-01-17 5 findings ARL Biopharma, Inc. dba Analytical Research LaboratoriesAseptic processing and sterility assurance · Laboratory and QC controls · Other quality system 2024-01-17 4 findings Pharmacy CreationsStability and storage · Aseptic processing and sterility assurance 2024-01-17 5 findings Eagle Analytical ServicesLaboratory and QC controls · Quality unit oversight · Computer system validation · Deviation, CAPA, and investigation · Training and personnel 2024-01-17 7 findings Beacon Hill Medical Pharmacy,P.C.Documentation and records · Process validation · Other quality system · Quality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage · Equipment and facility 2024-01-17 13 findings Pine Pharmacy and Home Care Products Center, Inc.Stability and storage · Aseptic processing and sterility assurance · Laboratory and QC controls · Contamination control · Quality unit oversight · Equipment and facility · Training and personnel 2024-01-17 10 findings Medi-Fare Drug and Home Health CenterContamination control · Training and personnel · Aseptic processing and sterility assurance 2024-01-17 3 findings Americare Compounding, LLC.Aseptic processing and sterility assurance · Training and personnel · Contamination control · Equipment and facility · Labeling and packaging · Other quality system · Stability and storage 2024-01-17 10 findings Home Infusions Solutions, Inc.Contamination control · Aseptic processing and sterility assurance · Equipment and facility · Stability and storage 2024-01-17 5 findings Total Pharmacy Services, Inc.Documentation and records · Aseptic processing and sterility assurance · Material and supplier control · Stability and storage · Training and personnel · Complaint and recall handling · Laboratory and QC controls 2024-01-17 11 findings Main Street Family PharmacyStability and storage · Aseptic processing and sterility assurance · Process validation · Material and supplier control · Contamination control · Equipment and facility · Quality unit oversight · Other quality system · Documentation and records · Training and personnel · Complaint and recall handling · Laboratory and QC controls · Environmental monitoring 2024-01-17 25 findings Gilead Sciences, IncOther quality system · Laboratory and QC controls · Equipment and facility · Quality unit oversight · Stability and storage · Process validation 2024-01-17 9 findings Hospira, Inc.Equipment and facility · Material and supplier control · Laboratory and QC controls · Complaint and recall handling · Process validation · Aseptic processing and sterility assurance · Other quality system · Training and personnel · Stability and storage 2024-01-17 19 findings Hospira Inc.Laboratory and QC controls · Process validation · Complaint and recall handling · Equipment and facility 2024-01-17 6 findings Novartis Consumer HealthStability and storage · Deviation, CAPA, and investigation · Quality unit oversight · Contamination control · Complaint and recall handling 2024-01-17 9 findings Hospira, IncTraining and personnel · Aseptic processing and sterility assurance · Equipment and facility · Material and supplier control · Laboratory and QC controls · Deviation, CAPA, and investigation · Process validation · Quality unit oversight · Other quality system 2024-01-17 20 findings Apothecure, Inc.Aseptic processing and sterility assurance · Other quality system · Contamination control · Equipment and facility · Laboratory and QC controls · Process validation · Material and supplier control · Documentation and records · Stability and storage · Complaint and recall handling 2024-01-17 13 findings NuVision Pharmacy, Inc.Material and supplier control · Stability and storage · Process validation · Laboratory and QC controls · Aseptic processing and sterility assurance · Training and personnel · Documentation and records 2024-01-17 11 findings Lowlyn Pharmacies, IncLaboratory and QC controls · Stability and storage · Equipment and facility · Aseptic processing and sterility assurance 2024-01-17 7 findings Axium Healthcare Pharmacy (dba Balanced Solutions Compounding)Laboratory and QC controls · Contamination control · Aseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Stability and storage 2024-01-17 7 findings Medi-Fare Drug & Home Health Center, Inc.Aseptic processing and sterility assurance · Other quality system · Complaint and recall handling · Deviation, CAPA, and investigation 2024-01-17 11 findings IV Solutions of LubbockEquipment and facility · Laboratory and QC controls · Training and personnel · Aseptic processing and sterility assurance 2024-01-17 7 findings Drugs are Us, Inc. (dba Hopewell Pharmacy)Stability and storage · Training and personnel · Aseptic processing and sterility assurance 2024-01-17 3 findings Nora Apothecary and Alternative Therapies, Inc.Laboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 6 findings Alexion Pharmaceuticals, Inc.Quality unit oversight · Deviation, CAPA, and investigation · Contamination control · Environmental monitoring 2024-01-17 7 findings Specialty Compounding PharmacyAseptic processing and sterility assurance · Stability and storage 2024-01-17 4 findings Medaus, Inc.Stability and storage · Aseptic processing and sterility assurance · Laboratory and QC controls · Process validation · Contamination control 2024-01-17 12 findings The Compounding ShopLaboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Stability and storage · Training and personnel 2024-01-17 12 findings The Compounding ShopEquipment and facility · Stability and storage · Aseptic processing and sterility assurance · Laboratory and QC controls · Training and personnel 2024-01-17 12 findings Pentec Health, Inc.Training and personnel · Equipment and facility · Stability and storage · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Other quality system · Material and supplier control · Contamination control 2024-01-17 9 findings Hospira Boulder, Inc.Other quality system · Quality unit oversight · Complaint and recall handling · Equipment and facility · Material and supplier control · Laboratory and QC controls 2024-01-17 7 findings Village Fertility Pharmacy, Inc.Other quality system · Aseptic processing and sterility assurance 2024-01-17 4 findings FVS Holdings, Inc. (dba Green Valley Drugs)Aseptic processing and sterility assurance · Stability and storage · Labeling and packaging · Contamination control · Training and personnel · Deviation, CAPA, and investigation · Laboratory and QC controls · Material and supplier control 2024-01-17 13 findings Stewart Compounding PharmacyAseptic processing and sterility assurance · Training and personnel · Stability and storage · Laboratory and QC controls 2024-01-17 10 findings RC Compounding Services, LLCLaboratory and QC controls · Documentation and records · Aseptic processing and sterility assurance · Process validation · Stability and storage 2024-01-17 6 findings Impax Laboratories, Inc.Other quality system · Deviation, CAPA, and investigation · Process validation 2024-01-17 5 findings Impax Laboratories, IncDocumentation and records · Complaint and recall handling · Stability and storage · Computer system validation · Material and supplier control · Deviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility · Other quality system · Training and personnel · Process validation 2024-01-17 12 findings RxSouth, LLC (dba RX3 Pharmacy)Equipment and facility · Other quality system · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls · Process validation · Environmental monitoring · Stability and storage · Documentation and records · Deviation, CAPA, and investigation 2024-01-17 13 findings Custom Compounding CenterTraining and personnel · Aseptic processing and sterility assurance · Other quality system · Environmental monitoring · Documentation and records 2024-01-17 14 findings Central Admixture Pharmacy Services, Inc. (CAPS)Contamination control · Other quality system · Aseptic processing and sterility assurance · Equipment and facility 2024-01-17 13 findings MedPREP Consulting Inc.Stability and storage · Other quality system · Material and supplier control · Documentation and records · Equipment and facility · Aseptic processing and sterility assurance · Training and personnel · Labeling and packaging · Laboratory and QC controls · Deviation, CAPA, and investigation · Environmental monitoring 2024-01-17 14 findings JCB Labs LLCDeviation, CAPA, and investigation · Laboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage 2024-01-17 4 findings Portage Pharmacy, Inc.Laboratory and QC controls · Aseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Stability and storage · Other quality system · Training and personnel 2024-01-17 13 findings Central Admixture Pharmacy Services, Inc. (CAPS)Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Contamination control · Complaint and recall handling · Aseptic processing and sterility assurance 2024-01-17 11 findings College Pharmacy IncorporatedAseptic processing and sterility assurance · Laboratory and QC controls · Material and supplier control · Stability and storage 2024-01-17 6 findings Lowlite Investments, Inc. (dba Olympia Pharmacy)Aseptic processing and sterility assurance · Laboratory and QC controls · Training and personnel · Stability and storage · Other quality system · Contamination control 2024-01-17 12 findings PharMEDium Services LLCMaterial and supplier control · Laboratory and QC controls · Aseptic processing and sterility assurance · Labeling and packaging · Equipment and facility · Process validation · Quality unit oversight 2024-01-17 12 findings Wedgewood Village Pharmacy, Inc.Other quality system · Documentation and records · Aseptic processing and sterility assurance · Complaint and recall handling · Material and supplier control 2024-01-17 10 findings Home Intensive Care Pharmacy, IncAseptic processing and sterility assurance · Stability and storage · Training and personnel 2024-01-17 7 findings Oakdell Pharmacy, Inc.Stability and storage · Aseptic processing and sterility assurance · Training and personnel 2024-01-17 7 findings Triangle Compounding, Cary, NCContamination control · Equipment and facility · Aseptic processing and sterility assurance · Process validation · Deviation, CAPA, and investigation 2024-01-17 5 findings Celltex Therapeutics CorporationProcess validation · Quality unit oversight · Other quality system · Equipment and facility · Material and supplier control · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2024-01-17 11 findings PharMEDium Service, Inc.Training and personnel · Laboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage · Equipment and facility 2024-01-17 9 findings University Pharmacy, Inc.Equipment and facility · Aseptic processing and sterility assurance · Stability and storage · Contamination control · Laboratory and QC controls 2024-01-17 6 findings Central Admixture Pharmacy Services, Inc., (CAPS)Aseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation · Documentation and records 2024-01-17 6 findings PharMEDium Services LLCLaboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage · Other quality system · Complaint and recall handling · Training and personnel 2024-01-17 7 findings AnazaoHealth CorporationAseptic processing and sterility assurance · Material and supplier control · Equipment and facility · Training and personnel · Stability and storage · Laboratory and QC controls · Process validation 2024-01-17 12 findings Central Admixture Pharmacy Services, Inc.Quality unit oversight · Equipment and facility · Other quality system · Material and supplier control 2024-01-17 6 findings Lee and Company dba Lee Pharmacy, Inc.Quality unit oversight · Aseptic processing and sterility assurance · Process validation · Material and supplier control 2024-01-17 6 findings Central Admixture Pharmacy Services, Inc.Stability and storage · Aseptic processing and sterility assurance · Material and supplier control · Training and personnel 2024-01-17 7 findings PharMEDium Services, LLCEquipment and facility · Process validation · Aseptic processing and sterility assurance · Laboratory and QC controls · Contamination control · Other quality system 2024-01-17 13 findings Ameridose, LLCAseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Process validation · Complaint and recall handling 2024-01-17 15 findings NECCAseptic processing and sterility assurance · Validation and qualification · Documentation and records 2024-01-17 4 findings New England Compounding CenterComplaint and recall handling · Aseptic processing and sterility assurance 2024-01-17 3 findings Ameridose, LLCDocumentation and records · Material and supplier control · Laboratory and QC controls 2024-01-17 5 findings APP PharmaceuticalsLaboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight · Other quality system · Complaint and recall handling · Documentation and records · Equipment and facility 2024-01-17 16 findings American Red Cross Blood ServicesOther quality system · Material and supplier control · Stability and storage 2024-01-17 8 findings American Red Cross Southeastern Michigan RegionTraining and personnel · Stability and storage · Aseptic processing and sterility assurance 2024-01-17 3 findings American National Red Cross Indiana-Ohio RegionOther quality system · Material and supplier control 2024-01-17 5 findings American National Red Cross Heart of America RegionComplaint and recall handling · Material and supplier control · Other quality system · Deviation, CAPA, and investigation 2024-01-17 5 findings American Red Cross Greater Alleghenies RegioMaterial and supplier control · Deviation, CAPA, and investigation · Quality unit oversight 2024-01-17 5 findings American Red Cross Blood ServicesDeviation, CAPA, and investigation · Material and supplier control 2024-01-17 3 findings Novartis Consumer HealthDeviation, CAPA, and investigation · Training and personnel · Validation and qualification · Quality unit oversight · Complaint and recall handling 2024-01-17 5 findings Novartis Consumer Health,Complaint and recall handling · Other quality system · Training and personnel · Deviation, CAPA, and investigation · Documentation and records · Quality unit oversight · Equipment and facility · Validation and qualification 2024-01-17 14 findings American Red Cross - Donor and Client Support CenterOther quality system · Quality unit oversight · Deviation, CAPA, and investigation · Equipment and facility 2024-01-17 7 findings American Red Cross Donor and Client Support CenterDeviation, CAPA, and investigation · Equipment and facility · Other quality system 2024-01-17 6 findings Akorn, Inc.Other quality system · Aseptic processing and sterility assurance · Complaint and recall handling · Laboratory and QC controls · Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Documentation and records · Material and supplier control 2024-01-17 13 findings Akorn, Inc.Material and supplier control · Process validation · Documentation and records · Quality unit oversight · Laboratory and QC controls · Stability and storage 2024-01-17 8 findings Hospira Boulder, Inc.Material and supplier control · Equipment and facility · Other quality system 2024-01-17 6 findings Professional Disposables International, Inc.Complaint and recall handling · Other quality system · Laboratory and QC controls 2024-01-17 3 findings Genentech Inc.Contamination control · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility 2024-01-17 4 findings Professional Disposables International, Inc.Other quality system · Deviation, CAPA, and investigation · Process validation 2024-01-17 3 findings Professional Disposables International, IncDocumentation and records · Quality unit oversight · Laboratory and QC controls · Deviation, CAPA, and investigation 2024-01-17 4 findings Ben Venue Laboratories, Inc.Validation and qualification · Aseptic processing and sterility assurance · Other quality system · Equipment and facility · Environmental monitoring · Stability and storage · Laboratory and QC controls · Material and supplier control · Training and personnel · Quality unit oversight 2024-01-17 21 findings Hospira Inc.Deviation, CAPA, and investigation · Other quality system · Process validation · Equipment and facility · Quality unit oversight · Stability and storage · Training and personnel · Contamination control · Complaint and recall handling 2024-01-17 18 findings Sandoz, Inc.Process validation · Equipment and facility · Quality unit oversight · Laboratory and QC controls · Deviation, CAPA, and investigation · Complaint and recall handling · Other quality system 2024-01-17 10 findings Sandoz, Inc.Laboratory and QC controls · Process validation · Material and supplier control · Quality unit oversight · Other quality system 2024-01-17 8 findings H & P Industries, Inc.Equipment and facility · Laboratory and QC controls · Process validation · Other quality system · Deviation, CAPA, and investigation 2024-01-17 10 findings H & P Industries, Inc.Equipment and facility · Laboratory and QC controls · Process validation · Deviation, CAPA, and investigation 2024-01-17 9 findings H & P Industries, Inc.Process validation · Other quality system · Aseptic processing and sterility assurance · Documentation and records · Laboratory and QC controls · Contamination control · Quality unit oversight · Stability and storage · Material and supplier control · Equipment and facility · Deviation, CAPA, and investigation · Training and personnel · Complaint and recall handling · Validation and qualification 2024-01-17 46 findings McNeil Consumer Healthcare Inc.Complaint and recall handling · Deviation, CAPA, and investigation · Process validation · Quality unit oversight 2024-01-17 7 findings H & P Industries, Inc.Equipment and facility · Material and supplier control · Laboratory and QC controls · Labeling and packaging · Quality unit oversight · Deviation, CAPA, and investigation · Other quality system · Process validation · Computer system validation · Contamination control 2024-01-17 18 findings H & P Industries, Inc.Material and supplier control · Deviation, CAPA, and investigation · Other quality system · Contamination control · Computer system validation · Labeling and packaging · Equipment and facility · Training and personnel · Process validation · Quality unit oversight 2024-01-17 17 findings H & P Industries, Inc.Aseptic processing and sterility assurance · Quality unit oversight · Other quality system · Deviation, CAPA, and investigation · Process validation 2024-01-17 14 findings H & P Industries, Inc.Equipment and facility · Other quality system · Deviation, CAPA, and investigation · Regulatory reporting and change control · Laboratory and QC controls · Stability and storage · Aseptic processing and sterility assurance · Quality unit oversight · Process validation · Complaint and recall handling · Training and personnel 2024-01-17 23 findings McNeil Consumer HealthcareLaboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight 2024-01-17 3 findings McNeil Consumer HealthcareEquipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight · Labeling and packaging · Other quality system · Documentation and records · Material and supplier control · Complaint and recall handling 2024-01-17 13 findings American Red Cross Blood ServicesQuality unit oversight · Other quality system · Deviation, CAPA, and investigation 2024-01-17 7 findings American Red Cross Blood ServicesMaterial and supplier control · Equipment and facility · Other quality system 2024-01-17 3 findings The American National Red CrossOther quality system · Regulatory reporting and change control 2024-01-17 3 findings American National Red CrossOther quality system 2024-01-17 3 findings McNeil Consumer and Specialty PharmaceuticalQuality unit oversight · Deviation, CAPA, and investigation · Process validation · Other quality system 2024-01-17 5 findings McNeil PPC, Inc.Material and supplier control · Complaint and recall handling · Process validation · Other quality system · Deviation, CAPA, and investigation 2024-01-17 6 findings McNeil Consumer HealthcareProcess validation · Equipment and facility · Laboratory and QC controls · Labeling and packaging · Training and personnel · Quality unit oversight · Material and supplier control · Other quality system · Deviation, CAPA, and investigation · Stability and storage · Documentation and records · Complaint and recall handling 2024-01-17 20 findings L. Perrigo Co.Equipment and facility · Material and supplier control · Other quality system · Quality unit oversight · Deviation, CAPA, and investigation · Laboratory and QC controls 2024-01-17 8 findings Scientific Protein LaboratoriesOther quality system · Validation and qualification · Process validation · Deviation, CAPA, and investigation · Training and personnel · Equipment and facility 2024-01-17 9 findings L. Perrigo CoEquipment and facility · Material and supplier control · Stability and storage · Quality unit oversight · Deviation, CAPA, and investigation · Laboratory and QC controls · Documentation and records · Training and personnel · Process validation · Other quality system · Complaint and recall handling 2024-01-17 19 findings L. Perrigo CoComplaint and recall handling · Deviation, CAPA, and investigation 2024-01-17 7 findings Scientific Protein LaboratoriesEquipment and facility · Complaint and recall handling · Material and supplier control 2024-01-17 3 findings L. Perrigo CoQuality unit oversight · Complaint and recall handling · Deviation, CAPA, and investigation · Laboratory and QC controls · Material and supplier control · Stability and storage 2024-01-17 10 findings L. Perrigo CoComplaint and recall handling · Training and personnel 2024-01-17 3 findings McNeil Healthcare, LLCDeviation, CAPA, and investigation · Quality unit oversight · Complaint and recall handling · Equipment and facility · Laboratory and QC controls 2024-01-17 7 findings McNeil Consumer HealthcareValidation and qualification · Deviation, CAPA, and investigation · Other quality system 2024-01-17 5 findings Johnson and Johnson (McNeil)Laboratory and QC controls · Deviation, CAPA, and investigation · Equipment and facility · Complaint and recall handling · Contamination control · Other quality system 2024-01-17 11 findings Unico Holdings, Inc.Other quality system · Material and supplier control · Quality unit oversight · Process validation · Stability and storage 2024-01-17 5 findings Unico Holdings, Inc.Contamination control · Equipment and facility · Other quality system 2024-01-17 4 findings Unico Holdings, Inc.Laboratory and QC controls · Equipment and facility · Contamination control 2024-01-17 3 findings L. Perrigo CoLaboratory and QC controls · Contamination control · Process validation · Equipment and facility 2024-01-17 5 findings American Red Cross Southeastern Michigan RegionQuality unit oversight · Other quality system · Training and personnel 2024-01-17 6 findings American Red Cross Blood ServicesMaterial and supplier control · Other quality system 2024-01-17 5 findings Ohm Laboratories, Inc.Computer system validation · Laboratory and QC controls · Stability and storage · Labeling and packaging · Complaint and recall handling · Quality unit oversight · Equipment and facility · Material and supplier control · Documentation and records · Other quality system · Process validation 2024-01-17 16 findings McNeil Consumer HealthcareEquipment and facility · Documentation and records · Process validation · Other quality system · Material and supplier control · Laboratory and QC controls · Quality unit oversight · Stability and storage · Training and personnel · Labeling and packaging · Complaint and recall handling · Deviation, CAPA, and investigation 2024-01-17 20 findings Care-Tech Labs, IncProcess validation · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Other quality system · Quality unit oversight · Documentation and records · Stability and storage · Material and supplier control 2024-01-17 23 findings Baxter Healthcare CorporationOther quality system · Equipment and facility · Process validation · Quality unit oversight 2024-01-17 4 findings Amylin Pharmaceuticals Inc.Other quality system · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Aseptic processing and sterility assurance · Process validation 2024-01-17 6 findings Unilever CovingtonDeviation, CAPA, and investigation · Aseptic processing and sterility assurance 2024-01-17 3 findings Genzyme CorporationOther quality system · Material and supplier control · Process validation · Training and personnel 2024-01-17 8 findings McNeil Healthcare, LLCLaboratory and QC controls · Deviation, CAPA, and investigation · Complaint and recall handling · Equipment and facility · Quality unit oversight 2024-01-17 7 findings Care-Tech Labs Inc.Material and supplier control · Equipment and facility · Other quality system · Quality unit oversight · Laboratory and QC controls · Process validation · Deviation, CAPA, and investigation · Stability and storage · Documentation and records 2024-01-17 19 findings Care-Tech Labs Inc.Other quality system · Equipment and facility · Documentation and records · Process validation · Laboratory and QC controls · Stability and storage · Deviation, CAPA, and investigation · Quality unit oversight · Material and supplier control 2024-01-17 19 findings Care-Tech Labs Inc.Process validation · Laboratory and QC controls · Material and supplier control · Equipment and facility · Documentation and records · Stability and storage · Deviation, CAPA, and investigation · Quality unit oversight · Other quality system 2024-01-17 19 findings Caraco Pharmaceutical LaboratoriesQuality unit oversight · Equipment and facility · Documentation and records 2024-01-17 5 findings Teva Parenteral Medicines, Inc.Material and supplier control · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight · Equipment and facility · Laboratory and QC controls · Other quality system 2024-01-17 12 findings American National Red Cross/Biomedical ServicesDeviation, CAPA, and investigation · Other quality system · Labeling and packaging · Quality unit oversight · Training and personnel · Material and supplier control · Complaint and recall handling · Documentation and records · Aseptic processing and sterility assurance · Regulatory reporting and change control 2024-01-17 83 findings Clarcon Biological Chemistry LaboratoryComplaint and recall handling · Equipment and facility · Other quality system · Documentation and records · Labeling and packaging · Training and personnel · Quality unit oversight · Material and supplier control · Laboratory and QC controls · Stability and storage · Process validation 2024-01-17 18 findings Genzyme CorporationDeviation, CAPA, and investigation · Other quality system · Validation and qualification 2024-01-17 6 findings Teva Parenteral Medicines, Inc.Quality unit oversight · Aseptic processing and sterility assurance · Other quality system · Equipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation · Material and supplier control 2024-01-17 12 findings TEVA Animal HealthLaboratory and QC controls · Quality unit oversight · Training and personnel · Process validation · Stability and storage · Complaint and recall handling · Material and supplier control · Other quality system · Equipment and facility · Deviation, CAPA, and investigation 2024-01-17 19 findings KV PharmaceuticalMaterial and supplier control · Other quality system · Deviation, CAPA, and investigation · Equipment and facility · Process validation · Laboratory and QC controls · Quality unit oversight · Documentation and records · Complaint and recall handling · Stability and storage 2024-01-17 35 findings Wyeth Pharmaceutical,Div Wyeth Holding CorpOther quality system · Labeling and packaging · Equipment and facility 2024-01-17 4 findings Time Cap Labs, Inc.Other quality system · Deviation, CAPA, and investigation · Regulatory reporting and change control · Labeling and packaging · Material and supplier control · Quality unit oversight · Stability and storage · Validation and qualification 2024-01-17 13 findings Bioport CorporationOther quality system · Deviation, CAPA, and investigation · Equipment and facility · Documentation and records · Laboratory and QC controls 2024-01-17 15 findings Eli Lilly and CompanyAseptic processing and sterility assurance · Computer system validation · Other quality system · Equipment and facility · Process validation · Deviation, CAPA, and investigation · Training and personnel · Documentation and records · Laboratory and QC controls · Environmental monitoring · Validation and qualification 2024-01-17 33 findings Schering-Plough Products, LLCOther quality system · Deviation, CAPA, and investigation · Stability and storage · Equipment and facility 2024-01-17 8 findings Schering-Plough Products, LLCMaterial and supplier control · Regulatory reporting and change control · Other quality system · Contamination control 2024-01-17 7 findings Schering-Plough Products, LLCValidation and qualification · Laboratory and QC controls · Deviation, CAPA, and investigation · Other quality system · Material and supplier control 2024-01-17 11 findings Schering-Plough Products, LLCOther quality system · Material and supplier control · Stability and storage · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2024-01-17 9 findings Able Laboratories, Inc.Process validation · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Quality unit oversight · Training and personnel 2024-01-17 9 findings Boston Scientific CorporationDeviation, CAPA, and investigation · Training and personnel · Other quality system 2024-01-17 7 findings Boston Scientifc CorporationOther quality system · Deviation, CAPA, and investigation 2024-01-17 6 findings Sanofi Pasteur, IncAseptic processing and sterility assurance · Validation and qualification · Stability and storage · Computer system validation · Contamination control · Equipment and facility · Complaint and recall handling · Other quality system · Quality unit oversight · Material and supplier control 2024-01-17 23 findings Andrx Pharmaceuticals, IncOther quality system · Process validation · Quality unit oversight · Deviation, CAPA, and investigation 2024-01-17 4 findings Apotheca, IncDocumentation and records · Process validation · Quality unit oversight · Deviation, CAPA, and investigation 2024-01-17 6 findings South Coast Specialty Compounding, Inc.Quality unit oversight · Aseptic processing and sterility assurance · Training and personnel · Contamination control · Equipment and facility 2024-01-17 7 findings Central Admixture Pharmacy Services, Inc. (CAPS)Aseptic processing and sterility assurance · Complaint and recall handling · Equipment and facility 2024-01-17 14 findings D.R. Pharmacy Inc.Other quality system · Stability and storage 2024-01-17 3 findings Inventive Infusion Solutions, LPAseptic processing and sterility assurance · Other quality system · Contamination control · Environmental monitoring 2024-01-17 8 findings Pharm D Solutions, LLCLabeling and packaging · Material and supplier control · Regulatory reporting and change control · Aseptic processing and sterility assurance · Process validation · Training and personnel · Stability and storage · Documentation and records · Laboratory and QC controls 2024-01-17 15 findings Auro PharmaciesAseptic processing and sterility assurance · Validation and qualification · Other quality system · Equipment and facility · Stability and storage · Material and supplier control 2024-01-17 8 findings Westlab Pharmacy, Inc. dba Westlab PharmacyMaterial and supplier control · Aseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls 2024-01-17 9 findings American Pharmacy of Illinois, Inc. dba Alwan Pharmacy and Compounding CenterOther quality system · Material and supplier control · Aseptic processing and sterility assurance · Equipment and facility 2024-01-17 5 findings Auro PharmaciesAseptic processing and sterility assurance · Other quality system · Material and supplier control · Equipment and facility · Stability and storage 2024-01-17 9 findings Nutrishare IncAseptic processing and sterility assurance · Equipment and facility · Environmental monitoring · Contamination control · Training and personnel · Validation and qualification 2024-01-17 9 findings Talon Compounding PharmacyEquipment and facility · Aseptic processing and sterility assurance · Environmental monitoring · Other quality system 2024-01-17 7 findings People’s Custom Rx and Clinical Care, LLCAseptic processing and sterility assurance · Other quality system · Equipment and facility 2024-01-17 3 findings Dolan Central Illinois Compounding LLC dba Preckshot Professional PharmacyEquipment and facility · Aseptic processing and sterility assurance · Other quality system 2024-01-17 5 findings Dolan Central Illinois Compounding LLC dba Preckshot Professional PharmacyAseptic processing and sterility assurance · Equipment and facility · Other quality system 2024-01-17 4 findings FH Investments Inc. dba Asteria HealthEquipment and facility · Laboratory and QC controls · Aseptic processing and sterility assurance 2024-01-17 3 findings Sharp Drugs, Inc.Aseptic processing and sterility assurance 2024-01-17 5 findings Drug Depot, Inc. dba APS PharmacyEquipment and facility · Aseptic processing and sterility assurance · Contamination control 2024-01-17 3 findings CFP Acquisitions, IncAseptic processing and sterility assurance · Environmental monitoring · Other quality system 2024-01-17 5 findings Pharmcore Inc. dba Hallandale PharmacyAseptic processing and sterility assurance · Validation and qualification 2024-01-17 3 findings Mylan Pharmaceuticals Inc.Process validation · Deviation, CAPA, and investigation · Quality unit oversight · Laboratory and QC controls · Equipment and facility · Complaint and recall handling 2024-01-17 12 findings Stokes Healthcare Inc.Labeling and packaging · Documentation and records · Stability and storage 2024-01-17 3 findings People’s Custom Rx and Clinical Care, LLCEquipment and facility · Aseptic processing and sterility assurance · Other quality system 2024-01-17 4 findings Well Care Discount Pharmacy, LLCOther quality system · Material and supplier control · Laboratory and QC controls 2024-01-17 3 findings La Vita Compounding Pharmacy, LLCAseptic processing and sterility assurance · Environmental monitoring · Contamination control 2024-01-17 4 findings Stonegate Pharmacy LPAseptic processing and sterility assurance · Training and personnel 2024-01-17 4 findings Home Care Pharmacy of Palm Coast, Inc.Contamination control · Material and supplier control 2024-01-17 3 findings Ranier’s Compounding LaboratoryAseptic processing and sterility assurance 2024-01-17 3 findings Eagle Pharmacy Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility 2024-01-17 4 findings Coast Quality Pharmacy LLCAseptic processing and sterility assurance · Laboratory and QC controls · Material and supplier control · Training and personnel · Deviation, CAPA, and investigation 2024-01-17 13 findings Guardian Pharmacy ServicesOther quality system · Aseptic processing and sterility assurance · Equipment and facility · Computer system validation · Complaint and recall handling · Material and supplier control · Quality unit oversight · Laboratory and QC controls · Deviation, CAPA, and investigation 2024-01-17 13 findings Pine Pharmaceuticals, LLCTraining and personnel · Labeling and packaging · Aseptic processing and sterility assurance 2024-01-17 3 findings Guardian Pharmacy ServicesAseptic processing and sterility assurance · Computer system validation · Other quality system · Quality unit oversight · Material and supplier control · Complaint and recall handling · Equipment and facility · Stability and storage · Deviation, CAPA, and investigation 2024-01-17 14 findings OPS International Incorporated D/B/A Olympia PharmacyContamination control · Labeling and packaging · Quality unit oversight · Regulatory reporting and change control · Aseptic processing and sterility assurance · Laboratory and QC controls 2024-01-17 9 findings Wells Pharmacy Network, LLCEquipment and facility · Deviation, CAPA, and investigation · Process validation · Aseptic processing and sterility assurance · Computer system validation · Quality unit oversight 2024-01-17 10 findings PharMEDium Services, LLCEquipment and facility · Training and personnel · Deviation, CAPA, and investigation · Documentation and records · Quality unit oversight 2024-01-17 6 findings QuVa Pharma, Inc.Quality unit oversight · Process validation · Aseptic processing and sterility assurance · Complaint and recall handling 2024-01-17 4 findings Medlife Pharmacy and CompoundingAseptic processing and sterility assurance · Material and supplier control · Contamination control · Process validation · Laboratory and QC controls · Stability and storage · Equipment and facility 2024-01-17 10 findings Chen Shwezin dba Park Compounding PharmacyLaboratory and QC controls · Equipment and facility · Material and supplier control · Contamination control 2024-01-17 5 findings Cantrell Drug CompanyLabeling and packaging · Complaint and recall handling · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Material and supplier control · Other quality system · Regulatory reporting and change control 2024-01-17 7 findings Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy)Aseptic processing and sterility assurance 2024-01-17 5 findings Edge Pharmacy Services, LLCComputer system validation · Aseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls · Training and personnel · Quality unit oversight · Labeling and packaging · Documentation and records 2024-01-17 12 findings West Coast Nuclear Pharmacy, LLCEnvironmental monitoring · Aseptic processing and sterility assurance · Equipment and facility 2024-01-17 5 findings SCA Pharmaceuticals, LLC.Aseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Laboratory and QC controls 2024-01-17 8 findings Coastal Meds, LLCEquipment and facility · Contamination control · Aseptic processing and sterility assurance · Material and supplier control · Quality unit oversight · Stability and storage · Labeling and packaging · Laboratory and QC controls 2024-01-17 10 findings Apollo Care LLCMaterial and supplier control · Documentation and records · Labeling and packaging 2024-01-17 3 findings SCA Pharmaceuticals, LLC.Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation · Quality unit oversight 2024-01-17 10 findings New England Life Care, Inc.Contamination control · Aseptic processing and sterility assurance 2024-01-17 5 findings Denver Solutions, LLC dba Leiter's HealthAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls 2024-01-17 4 findings Pentec HealthEquipment and facility · Documentation and records · Process validation · Quality unit oversight · Aseptic processing and sterility assurance 2024-01-17 5 findings RC Compounding Services, LLCAseptic processing and sterility assurance · Training and personnel · Contamination control · Equipment and facility 2024-01-17 6 findings New England Life Care, Inc.Aseptic processing and sterility assurance · Contamination control 2024-01-17 5 findings Option Care Enterprises Inc. dba Option CareAseptic processing and sterility assurance · Equipment and facility 2024-01-17 4 findings Infusion Partners, LLCAseptic processing and sterility assurance · Equipment and facility · Contamination control · Training and personnel · Other quality system 2024-01-17 10 findings Professional Arts PharmacyOther quality system · Contamination control · Material and supplier control 2024-01-17 3 findings College Pharmacy, Inc.Contamination control · Aseptic processing and sterility assurance · Training and personnel · Other quality system 2024-01-17 5 findings Cape DrugsEquipment and facility · Material and supplier control 2024-01-17 3 findings Techni Med, Inc. dba The CompounderDocumentation and records · Aseptic processing and sterility assurance · Laboratory and QC controls · Contamination control · Stability and storage 2024-01-17 5 findings PharMEDium Services, LLCAseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation · Other quality system · Quality unit oversight 2024-01-17 10 findings KRS Global Biotechnology, Inc.Laboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation 2024-01-17 3 findings PharMEDium Services, LLC.Laboratory and QC controls · Process validation · Contamination control · Deviation, CAPA, and investigation · Other quality system · Labeling and packaging · Complaint and recall handling · Aseptic processing and sterility assurance · Documentation and records · Equipment and facility 2024-01-17 12 findings Intrathecal Compounding Specialists, LLCAseptic processing and sterility assurance · Other quality system · Training and personnel · Validation and qualification · Contamination control 2024-01-17 14 findings Diplomat Pharmacy Inc. dba Diplomat Specialty PharmacyAseptic processing and sterility assurance · Other quality system 2024-01-17 4 findings Guardian Pharmacy ServicesAseptic processing and sterility assurance · Complaint and recall handling · Equipment and facility · Other quality system · Deviation, CAPA, and investigation 2024-01-17 8 findings PharMEDium Services, LLC.Training and personnel · Quality unit oversight · Stability and storage · Labeling and packaging · Material and supplier control · Complaint and recall handling · Deviation, CAPA, and investigation · Equipment and facility · Other quality system · Aseptic processing and sterility assurance 2024-01-17 13 findings PharMEDium Services, LLCAseptic processing and sterility assurance · Laboratory and QC controls · Labeling and packaging · Other quality system · Equipment and facility 2024-01-17 6 findings American CryoStem CorporationEquipment and facility · Stability and storage · Material and supplier control · Process validation · Aseptic processing and sterility assurance 2024-01-17 7 findings Baxter Healthcare CorporationQuality unit oversight · Equipment and facility · Material and supplier control · Process validation 2024-01-17 5 findings SCA Pharmaceuticals, LLCTraining and personnel · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Labeling and packaging 2024-01-17 6 findings SSM Health Care St. Louis DBA SSM St. Clare Health CenterEquipment and facility · Aseptic processing and sterility assurance · Labeling and packaging · Deviation, CAPA, and investigation · Stability and storage 2024-01-17 6 findings Dignity Health-Northridge Hospital Medical CenterAseptic processing and sterility assurance · Environmental monitoring · Equipment and facility 2024-01-17 9 findings Prescription Labs, Inc. dba Greenpark Compounding PharmacyAseptic processing and sterility assurance · Validation and qualification 2024-01-17 4 findings United Pharmacy, LLCTraining and personnel · Other quality system · Contamination control · Aseptic processing and sterility assurance 2024-01-17 8 findings Banner Pharmacy Services, LLCAseptic processing and sterility assurance · Quality unit oversight · Labeling and packaging · Training and personnel · Deviation, CAPA, and investigation · Laboratory and QC controls 2024-01-17 11 findings Banner Pharmacy Services, LLCQuality unit oversight · Training and personnel · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls · Labeling and packaging · Regulatory reporting and change control 2024-01-17 11 findings Akorn, Inc.Equipment and facility · Quality unit oversight · Aseptic processing and sterility assurance 2024-01-17 3 findings Akorn, Inc.Aseptic processing and sterility assurance · Equipment and facility · Quality unit oversight 2024-01-17 3 findings Meridian Medical Technologies, Inc. a Pfizer CompanyProcess validation · Validation and qualification · Other quality system · Laboratory and QC controls · Complaint and recall handling · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Training and personnel · Quality unit oversight 2024-01-17 13 findings Central Illinois Compounding, Inc. dba Preckshot Professional PharmacyEquipment and facility · Other quality system · Aseptic processing and sterility assurance 2024-01-17 4 findings RXQ Compounding LLCValidation and qualification · Process validation · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls · Documentation and records 2024-01-17 8 findings New England Life Care, Inc., dba Advanced Compounding SolutionsOther quality system · Material and supplier control · Regulatory reporting and change control · Complaint and recall handling · Aseptic processing and sterility assurance 2024-01-17 6 findings Carepoint Healthcare, LLC dba Carepoint PharmacyAseptic processing and sterility assurance 2024-01-17 3 findings Stanley Specialty Pharmacy Compounding and Wellness CenterAseptic processing and sterility assurance · Other quality system 2024-01-17 3 findings New England Life Care, Inc., dba Advanced Compounding SolutionsLaboratory and QC controls · Aseptic processing and sterility assurance · Material and supplier control · Equipment and facility · Complaint and recall handling 2024-01-17 6 findings US Specialty Formulations LLCComputer system validation · Training and personnel · Equipment and facility · Laboratory and QC controls · Labeling and packaging 2024-01-17 5 findings Triad Rx, Inc.Aseptic processing and sterility assurance · Environmental monitoring · Equipment and facility 2024-01-17 9 findings Mytilini Enterprises LLC dba Bedford Pharmacy Inc.Equipment and facility · Laboratory and QC controls · Stability and storage · Material and supplier control · Contamination control 2024-01-17 6 findings Heartland Home Infusions, Inc., dba HHI Infusion ServicesContamination control · Environmental monitoring 2024-01-17 3 findings US Stem Cell Clinic, LLCAseptic processing and sterility assurance · Documentation and records · Quality unit oversight · Other quality system · Process validation · Material and supplier control · Laboratory and QC controls · Equipment and facility · Training and personnel 2024-01-17 12 findings Tri-Med Inc. dba Advanced Care Infusion-ShelbyAseptic processing and sterility assurance 2024-01-17 3 findings First Call Pharmacy, LLCAseptic processing and sterility assurance · Environmental monitoring · Equipment and facility 2024-01-17 4 findings Infusion Systems of SW Florida Inc. dba Myerlee PharmacyAseptic processing and sterility assurance · Process validation · Equipment and facility · Contamination control · Laboratory and QC controls · Material and supplier control 2024-01-17 8 findings Kelley-Ross Compounding PharmacyAseptic processing and sterility assurance · Environmental monitoring · Equipment and facility · Validation and qualification · Contamination control 2024-01-17 7 findings Jeffreys Drug StoreAseptic processing and sterility assurance 2024-01-17 3 findings Kelley-Ross Compounding PharmacyAseptic processing and sterility assurance 2024-01-17 3 findings Imprimis NJOF, LLCQuality unit oversight · Material and supplier control · Training and personnel · Process validation · Deviation, CAPA, and investigation · Equipment and facility · Laboratory and QC controls · Aseptic processing and sterility assurance 2024-01-17 10 findings One Way Drug, LLC dba Partell Specialty PharmacyEquipment and facility · Other quality system · Laboratory and QC controls 2024-01-17 3 findings Triangle Compounding Pharmacy IncDeviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance · Quality unit oversight · Contamination control · Other quality system · Laboratory and QC controls · Material and supplier control 2024-01-17 10 findings Buffalo Pharmacies Inc.Aseptic processing and sterility assurance · Training and personnel · Equipment and facility 2024-01-17 5 findings Boothwyn Pharmacy LLC.Aseptic processing and sterility assurance · Stability and storage · Equipment and facility 2024-01-17 10 findings California Stem Cell TreatmentAseptic processing and sterility assurance · Material and supplier control · Documentation and records · Equipment and facility · Training and personnel · Laboratory and QC controls · Complaint and recall handling · Quality unit oversight 2024-01-17 11 findings California Stem Cell Treatment Center/Cell Surgical NetworkLaboratory and QC controls · Training and personnel · Material and supplier control · Aseptic processing and sterility assurance · Quality unit oversight · Documentation and records · Complaint and recall handling · Equipment and facility · Process validation 2024-01-17 13 findings Auro Pharmacies Inc.Deviation, CAPA, and investigation · Quality unit oversight · Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility · Stability and storage 2024-01-17 11 findings LEESAR, INCAseptic processing and sterility assurance · Deviation, CAPA, and investigation 2024-01-17 4 findings I.V. Specialty Ltd.Validation and qualification · Environmental monitoring · Aseptic processing and sterility assurance 2024-01-17 3 findings Cantrell Drug CompanyOther quality system · Deviation, CAPA, and investigation · Labeling and packaging · Aseptic processing and sterility assurance · Quality unit oversight · Stability and storage 2024-01-17 8 findings Buderer Drug Company, Inc.Other quality system · Aseptic processing and sterility assurance 2024-01-17 3 findings Snyder Mark Drugs Roselle, Inc. dba Mark Drugs PharmacyAseptic processing and sterility assurance · Stability and storage · Training and personnel · Laboratory and QC controls 2024-01-17 6 findings Sincerus Florida, LLC.Material and supplier control · Aseptic processing and sterility assurance · Labeling and packaging 2024-01-17 3 findings Pharmacy Resources IncorporatedStability and storage · Contamination control · Equipment and facility · Aseptic processing and sterility assurance · Laboratory and QC controls 2024-01-17 7 findings Park Infusioncare LP dba Preferred HomecareAseptic processing and sterility assurance · Equipment and facility 2024-01-17 5 findings ARJ Infusion Services, Inc.Aseptic processing and sterility assurance 2024-01-17 3 findings Brookfield PharmacyOther quality system · Equipment and facility · Environmental monitoring · Validation and qualification 2024-01-17 5 findings Absolute Veterinary Compounding PharmacyDeviation, CAPA, and investigation · Contamination control · Aseptic processing and sterility assurance · Other quality system 2024-01-17 5 findings Millers of Wyckoff, Inc.Aseptic processing and sterility assurance · Material and supplier control · Environmental monitoring · Laboratory and QC controls 2024-01-17 4 findings Pharmacy Associates, Inc.Contamination control · Aseptic processing and sterility assurance · Environmental monitoring · Training and personnel 2024-01-17 8 findings Diabetes Corporation of America dba DCA PharmacyOther quality system · Aseptic processing and sterility assurance · Equipment and facility 2024-01-17 5 findings Coram Healthcare Corporation of IndianaCleaning validation · Aseptic processing and sterility assurance · Environmental monitoring 2024-01-17 4 findings Vital Rx, Inc. dba Atlantic Pharmacy and CompoundingEnvironmental monitoring · Equipment and facility · Aseptic processing and sterility assurance · Other quality system 2024-01-17 4 findings Right Value Drug Stores, Inc.Equipment and facility · Laboratory and QC controls · Quality unit oversight · Documentation and records · Regulatory reporting and change control 2024-01-17 6 findings Bella Pharmaceuticals, Inc.Aseptic processing and sterility assurance · Training and personnel · Other quality system · Labeling and packaging · Stability and storage 2024-01-17 11 findings Infusion Options, Inc.Labeling and packaging · Aseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight · Training and personnel 2024-01-17 6 findings Qualgen LLCDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls · Process validation · Contamination control 2024-01-17 5 findings Shiraz Specialty Pharmacy Inc. dba Axis Pharmacy NorthwestEquipment and facility · Material and supplier control 2024-01-17 4 findings Sancilio & Company, Inc.Equipment and facility · Stability and storage · Laboratory and QC controls · Computer system validation · Deviation, CAPA, and investigation 2024-01-17 6 findings RC Outsourcing LLCAseptic processing and sterility assurance · Training and personnel · Other quality system · Deviation, CAPA, and investigation · Laboratory and QC controls 2024-01-17 9 findings Brookfield Medical/Surgical Supply Inc.Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Process validation 2024-01-17 4 findings Brookfield Medical/Surgical Supply Inc.Other quality system · Deviation, CAPA, and investigation · Process validation · Aseptic processing and sterility assurance 2024-01-17 5 findings California Pharmacy & Compounding CenterEquipment and facility · Documentation and records · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2024-01-17 6 findings RAM Pharma, Inc.Training and personnel · Aseptic processing and sterility assurance · Regulatory reporting and change control · Labeling and packaging · Equipment and facility · Laboratory and QC controls · Quality unit oversight 2024-01-17 12 findings SterRxStability and storage · Labeling and packaging · Aseptic processing and sterility assurance 2024-01-17 5 findings AnazaoHealth CorporationAseptic processing and sterility assurance · Training and personnel · Deviation, CAPA, and investigation · Regulatory reporting and change control 2024-01-17 6 findings Nephron Pharmaceuticals CorporationAseptic processing and sterility assurance · Quality unit oversight · Laboratory and QC controls · Labeling and packaging 2024-01-17 4 findings Delta Pharma Inc.Equipment and facility · Stability and storage · Material and supplier control · Labeling and packaging · Aseptic processing and sterility assurance · Laboratory and QC controls 2024-01-17 6 findings AnazaoHealth CorporationTraining and personnel · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Regulatory reporting and change control 2024-01-17 6 findings Compounded Solutions in Pharmacy LLCAseptic processing and sterility assurance · Equipment and facility · Contamination control · Training and personnel 2024-01-17 5 findings Puget Sound Drug Corporation dba Key Compounding PharmacyAseptic processing and sterility assurance · Contamination control · Deviation, CAPA, and investigation · Equipment and facility · Validation and qualification 2024-01-17 9 findings Hieber’s PharmacyAseptic processing and sterility assurance · Stability and storage · Training and personnel · Laboratory and QC controls 2024-01-17 8 findings Overton Brooks VA Medical CenterEquipment and facility · Aseptic processing and sterility assurance · Training and personnel 2024-01-17 10 findings ImprimisRx CA Inc. dba ImprimisRxAseptic processing and sterility assurance · Complaint and recall handling · Quality unit oversight 2024-01-17 3 findings ZS Pharma, Inc.Other quality system · Laboratory and QC controls · Quality unit oversight · Computer system validation · Equipment and facility · Cleaning validation 2024-01-17 6 findings Civic Center Pharmacy Inc.Aseptic processing and sterility assurance · Training and personnel · Documentation and records 2024-01-17 5 findings Isomeric Pharmacy Solutions LLCComplaint and recall handling · Quality unit oversight · Equipment and facility · Contamination control · Stability and storage · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Process validation · Training and personnel · Other quality system · Laboratory and QC controls 2024-01-17 14 findings MedPark Pharmacy LLCAseptic processing and sterility assurance 2024-01-17 4 findings PharMerica LLCAseptic processing and sterility assurance · Other quality system · Environmental monitoring 2024-01-17 5 findings Barclay Luke & Pillai Specialty Pharmacy PLLC dba Meta Pharmacy ServicesTraining and personnel · Equipment and facility · Quality unit oversight · Laboratory and QC controls · Documentation and records · Material and supplier control · Stability and storage 2024-01-17 10 findings Edge Pharmacy Services, LLCEquipment and facility · Quality unit oversight · Contamination control · Aseptic processing and sterility assurance 2024-01-17 4 findings Fallon Wellness Pharmacy LLCDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Contamination control · Equipment and facility · Other quality system 2024-01-17 10 findings Magellan Rx Pharmacy LLCAseptic processing and sterility assurance 2024-01-17 3 findings In Your Atmosphere Holdings LLC, (dba Highland Pharmacy)Equipment and facility · Laboratory and QC controls · Training and personnel · Process validation · Stability and storage · Quality unit oversight 2024-01-17 8 findings Fagron Compounding Services LLC dba Fagron Sterile ServicesLaboratory and QC controls · Deviation, CAPA, and investigation · Training and personnel · Aseptic processing and sterility assurance 2024-01-17 4 findings Auro Pharmacies, Inc.Deviation, CAPA, and investigation · Laboratory and QC controls · Quality unit oversight · Stability and storage · Training and personnel · Material and supplier control · Aseptic processing and sterility assurance · Contamination control 2024-01-17 14 findings Auro Pharmacies, Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Training and personnel · Deviation, CAPA, and investigation · Contamination control · Material and supplier control · Quality unit oversight · Stability and storage 2024-01-17 14 findings First Pharma Associates LLC dba Riverpoint PharmacyEquipment and facility · Validation and qualification · Other quality system · Environmental monitoring 2024-01-17 4 findings Loop Pharmacy & Home MedicalTraining and personnel · Aseptic processing and sterility assurance · Contamination control · Material and supplier control · Stability and storage 2024-01-17 9 findings Resource Optimization & Innovation LLCLabeling and packaging · Material and supplier control · Aseptic processing and sterility assurance · Documentation and records 2024-01-17 5 findings QuVa Pharma Inc.Labeling and packaging · Aseptic processing and sterility assurance 2024-01-17 3 findings DCA Inc. dba Beacon PrescriptionsLaboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation · Labeling and packaging 2024-01-17 7 findings Wells Pharmacy Network LLCOther quality system · Equipment and facility · Environmental monitoring · Contamination control · Aseptic processing and sterility assurance 2024-01-17 6 findings San Diego Compounding PharmacyAseptic processing and sterility assurance 2024-01-17 3 findings Tri-Coast Pharmacy Inc.Environmental monitoring · Material and supplier control · Aseptic processing and sterility assurance 2024-01-17 5 findings Cantrell Drug CompanyStability and storage · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Labeling and packaging · Laboratory and QC controls 2024-01-17 12 findings Cantrell Drug CompanyEquipment and facility · Other quality system · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Labeling and packaging · Stability and storage · Laboratory and QC controls 2024-01-17 12 findings Ladd Family Pharmacy LLCOther quality system · Stability and storage · Contamination control · Equipment and facility 2024-01-17 4 findings Montana Compounding Pharmacy P.C.Contamination control · Material and supplier control 2024-01-17 3 findings Strohecker's PharmacyAseptic processing and sterility assurance · Documentation and records 2024-01-17 4 findings Cantrell Drug CompanyAseptic processing and sterility assurance · Laboratory and QC controls · Labeling and packaging · Deviation, CAPA, and investigation · Stability and storage · Equipment and facility 2024-01-17 12 findings Rx Compounding Inc. dba Nora ApothecaryOther quality system · Validation and qualification · Environmental monitoring · Aseptic processing and sterility assurance · Contamination control 2024-01-17 8 findings Rx Compounding Inc. dba Nora ApothecaryContamination control · Aseptic processing and sterility assurance · Validation and qualification · Other quality system 2024-01-17 6 findings KRS Global Biotechnology Inc.Aseptic processing and sterility assurance · Training and personnel 2024-01-17 5 findings Akina PharmacyQuality unit oversight · Cleaning validation · Laboratory and QC controls · Equipment and facility · Complaint and recall handling 2024-01-17 5 findings Crosby’s Drugs Inc.Aseptic processing and sterility assurance · Stability and storage · Training and personnel · Equipment and facility · Contamination control 2024-01-17 8 findings Moore's Pharmacy Inc.Deviation, CAPA, and investigation · Process validation · Equipment and facility 2024-01-17 4 findings Bayview Pharmacy Inc.Aseptic processing and sterility assurance · Contamination control · Equipment and facility 2024-01-17 3 findings Wells Pharmacy Network LLCAseptic processing and sterility assurance · Other quality system · Contamination control 2024-01-17 6 findings Town and Country Compounding and Consultation Services LLCAseptic processing and sterility assurance · Contamination control · Other quality system 2024-01-17 7 findings California Pharmacy & Compounding CenterAseptic processing and sterility assurance · Labeling and packaging 2024-01-17 5 findings Maplerose Enterprises LLC dba Pencol PharmacyStability and storage · Contamination control · Equipment and facility · Quality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance · Material and supplier control 2024-01-17 10 findings Mooney's Pharmacy Inc.Contamination control · Other quality system 2024-01-17 3 findings MiMedx Group, Inc.Quality unit oversight · Laboratory and QC controls · Other quality system · Aseptic processing and sterility assurance · Process validation 2024-01-09 6 findings Curexa – East, LLC dba CurexaCleaning validation · Material and supplier control · Equipment and facility · Contamination control 2024-01-09 8 findings Prime Lab LLCQuality unit oversight · Material and supplier control · Equipment and facility 2024-01-09 3 findings Kimera Labs, Inc.Material and supplier control · Aseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight · Stability and storage 2024-01-04 9 findings