US FDA · 2022

Glenmark Pharmaceuticals Ltd.Documentation and records · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls 2022-12-28 4 findings MD Pharmaceutical Supply, LLCStability and storage · Documentation and records · Complaint and recall handling 2022-12-27 3 findings South Berwick Pharmacy Seacoast Compounding, Inc.Contamination control · Material and supplier control · Equipment and facility 2022-12-20 4 findings Pharmacy Plus, Inc. dba Vital Care CompounderAseptic processing and sterility assurance · Contamination control · Training and personnel 2022-12-20 9 findings DuPont Nutrition USA Inc.Material and supplier control · Deviation, CAPA, and investigation · Complaint and recall handling · Laboratory and QC controls 2022-12-20 4 findings Sagent Pharmaceuticals, Inc.Aseptic processing and sterility assurance · Quality unit oversight · Equipment and facility · Environmental monitoring · Contamination control · Deviation, CAPA, and investigation 2022-12-20 22 findings Arnold Professional PharmacyContamination control · Equipment and facility 2022-12-15 3 findings Centrient Pharmaceuticals India Private LimitedData integrity · Cleaning validation · Environmental monitoring 2022-12-13 3 findings QuVa Pharma , Inc.Aseptic processing and sterility assurance · Computer system validation · Process validation · Deviation, CAPA, and investigation 2022-12-07 5 findings Curexa - East, LLC dba CurexaContamination control · Other quality system 2022-12-07 3 findings QuVa Pharma, Inc.Labeling and packaging · Other quality system · Aseptic processing and sterility assurance · Documentation and records 2022-12-07 4 findings Rx Unlimited PharmacyTraining and personnel · Other quality system · Material and supplier control · Contamination control 2022-12-07 4 findings Kari Gran Inc.Quality unit oversight · Material and supplier control · Laboratory and QC controls · Documentation and records 2022-12-06 4 findings AG Hair LimitedLaboratory and QC controls · Material and supplier control · Deviation, CAPA, and investigation 2022-12-06 3 findings Glenmark Pharmaceuticals LimitedDeviation, CAPA, and investigation · Laboratory and QC controls · Process validation · Documentation and records 2022-12-06 4 findings Shuzy Rock Inc.Quality unit oversight · Process validation · Laboratory and QC controls 2022-11-29 3 findings Lynn Oaks Compounding PharmacyContamination control · Laboratory and QC controls · Equipment and facility · Stability and storage · Material and supplier control 2022-11-28 7 findings Qualgen, LLCOther quality system · Material and supplier control · Labeling and packaging · Quality unit oversight · Documentation and records · Laboratory and QC controls 2022-11-28 6 findings Be Well Natural MedicineAseptic processing and sterility assurance 2022-11-28 4 findings Invitrx Therapeutics, Inc.Laboratory and QC controls · Quality unit oversight · Stability and storage · Complaint and recall handling · Aseptic processing and sterility assurance · Documentation and records · Material and supplier control · Process validation 2022-11-22 10 findings AnazaoHealth CorporationMaterial and supplier control · Process validation · Laboratory and QC controls 2022-11-21 3 findings Right Value Drug Stores, LLC dba Carie Boyd's Prescription ShopAseptic processing and sterility assurance · Equipment and facility · Labeling and packaging · Documentation and records · Material and supplier control · Regulatory reporting and change control · Deviation, CAPA, and investigation 2022-11-21 9 findings Carolina InfusionEquipment and facility · Aseptic processing and sterility assurance · Material and supplier control · Validation and qualification 2022-11-16 5 findings Omega & Delta Co., Inc.Material and supplier control · Process validation · Quality unit oversight 2022-11-08 3 findings ImprimisRx NJAseptic processing and sterility assurance · Equipment and facility · Other quality system · Contamination control · Validation and qualification 2022-11-07 9 findings Mandell’s Clinical PharmacyTraining and personnel · Aseptic processing and sterility assurance 2022-11-07 4 findings Drug Depot, LLC., dba APS PharmacyAseptic processing and sterility assurance 2022-11-07 4 findings Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLCLaboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Other quality system 2022-11-01 9 findings Lupin LimitedCleaning validation · Deviation, CAPA, and investigation · Other quality system 2022-11-01 3 findings New England Life Care Inc. dba AdvancedLabeling and packaging · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility 2022-10-28 7 findings TMC Acquisition LLC dba Tailor Made CompoundingTraining and personnel · Contamination control · Validation and qualification · Equipment and facility · Aseptic processing and sterility assurance · Material and supplier control 2022-10-28 13 findings Jubilant Generics Ltd.Quality unit oversight · Deviation, CAPA, and investigation · Documentation and records · Other quality system 2022-10-25 6 findings Nephron SC Inc.Aseptic processing and sterility assurance 2022-10-25 3 findings Catalent Belgium SAOther quality system · Process validation · Computer system validation · Aseptic processing and sterility assurance 2022-10-20 9 findings Catalent Indiana, LLCOther quality system · Equipment and facility · Aseptic processing and sterility assurance · Process validation · Complaint and recall handling · Laboratory and QC controls · Deviation, CAPA, and investigation 2022-10-19 11 findings Compound Preferred LLCAseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight · Equipment and facility 2022-10-19 7 findings American Cleaning SolutionsProcess validation · Material and supplier control · Quality unit oversight · Equipment and facility 2022-10-18 4 findings Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing Lvsan Technology Co., Ltd.Material and supplier control · Documentation and records · Process validation · Cleaning validation 2022-10-18 5 findings Empower Clinic Services LLC dba Empower PharmacyAseptic processing and sterility assurance · Other quality system · Material and supplier control · Regulatory reporting and change control · Labeling and packaging · Quality unit oversight · Laboratory and QC controls · Process validation · Deviation, CAPA, and investigation 2022-10-11 15 findings Sterling Pharmaceutical Services, LLCAseptic processing and sterility assurance 2022-10-04 3 findings North American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingAseptic processing and sterility assurance · Material and supplier control · Contamination control 2022-09-27 8 findings Optum Infusion 483 Issued 03/18/2022Aseptic processing and sterility assurance · Other quality system 2022-09-27 6 findings Expert Compounding PharmacyLaboratory and QC controls · Documentation and records · Contamination control · Material and supplier control 2022-09-27 5 findings Revive Rx LLCAseptic processing and sterility assurance · Environmental monitoring · Equipment and facility 2022-09-27 8 findings Westlab Pharmacy Inc. dba Westlab PharmacyEquipment and facility · Environmental monitoring · Aseptic processing and sterility assurance · Material and supplier control · Contamination control 2022-09-27 7 findings Zhejiang Tianyu Pharmaceutical Co., Ltd.Cleaning validation · Deviation, CAPA, and investigation · Other quality system 2022-09-27 3 findings System Kosmetik Produktionsgesellschaft fur kosmetische GmbhLaboratory and QC controls · Material and supplier control · Process validation · Data integrity 2022-09-27 4 findings Olympia Compounding Pharmacy dba Olympia PharmacyOther quality system · Labeling and packaging · Quality unit oversight · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Regulatory reporting and change control · Stability and storage · Process validation 2022-09-26 13 findings US Specialty Formulations LLCDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls · Regulatory reporting and change control · Equipment and facility · Contamination control · Labeling and packaging 2022-09-26 15 findings Delta Pharma, Inc.Training and personnel · Aseptic processing and sterility assurance · Equipment and facility 2022-09-26 5 findings Fagron Compounding ServicesLaboratory and QC controls · Process validation · Quality unit oversight · Regulatory reporting and change control · Aseptic processing and sterility assurance 2022-09-22 6 findings Brookfield Medical /Surgical Supply Inc.Equipment and facility · Process validation · Aseptic processing and sterility assurance 2022-09-22 5 findings Farmakeio Outsourcing LLCLaboratory and QC controls · Stability and storage · Other quality system · Labeling and packaging 2022-09-22 7 findings Cipla LimitedComputer system validation · Aseptic processing and sterility assurance · Equipment and facility · Other quality system 2022-09-21 6 findings BioLab Sciences, Inc.Laboratory and QC controls · Environmental monitoring · Aseptic processing and sterility assurance · Quality unit oversight · Equipment and facility · Stability and storage · Process validation 2022-09-20 9 findings AlvotechComplaint and recall handling · Validation and qualification · Material and supplier control · Other quality system · Deviation, CAPA, and investigation · Laboratory and QC controls 2022-09-13 12 findings Sanitizer Supply LLCQuality unit oversight · Laboratory and QC controls · Material and supplier control 2022-09-13 3 findings Vita Pharmacy, LLC dba Talon Pharmacy of BoerneAseptic processing and sterility assurance · Environmental monitoring · Equipment and facility 2022-09-13 10 findings Hugel Inc.Contamination control · Environmental monitoring · Other quality system 2022-09-06 3 findings Gordon Laboratories Inc.Material and supplier control · Deviation, CAPA, and investigation · Quality unit oversight 2022-08-30 3 findings Green Wave Analytical, LLCQuality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance · Computer system validation 2022-08-30 5 findings Episciences Inc.Deviation, CAPA, and investigation · Process validation · Laboratory and QC controls · Material and supplier control 2022-08-30 4 findings Sun Pharmaceuticals Industries LimitedLaboratory and QC controls · Quality unit oversight · Deviation, CAPA, and investigation · Material and supplier control 2022-08-18 6 findings Verde Cosmetic Labs LLCQuality unit oversight · Deviation, CAPA, and investigation · Cleaning validation 2022-08-16 3 findings Valley BiosystemsLaboratory and QC controls 2022-08-09 5 findings Vitti Labs, LLCQuality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage 2022-08-09 6 findings DSP Skin Care LLCStability and storage · Laboratory and QC controls · Quality unit oversight 2022-08-02 3 findings Custom Research Labs Inc.Stability and storage · Material and supplier control · Documentation and records · Process validation 2022-07-26 4 findings Jost Chemical Co.Computer system validation · Complaint and recall handling · Laboratory and QC controls · Cleaning validation 2022-07-26 4 findings Genlabs CorporationQuality unit oversight · Process validation · Equipment and facility · Laboratory and QC controls 2022-07-19 4 findings Mirfeel Korea Co., Ltd.Material and supplier control · Stability and storage · Laboratory and QC controls 2022-06-28 3 findings Monarch PCM, LLCStability and storage · Quality unit oversight · Deviation, CAPA, and investigation 2022-06-28 3 findings Re-Gen Active Lab, Inc.Equipment and facility · Material and supplier control · Aseptic processing and sterility assurance · Documentation and records · Process validation · Stability and storage 2022-06-28 9 findings Expert Compounding PharmacyContamination control · Laboratory and QC controls · Material and supplier control · Documentation and records 2022-06-24 5 findings Davis City Pharmacy Inc.Laboratory and QC controls · Other quality system · Documentation and records · Contamination control 2022-06-24 5 findings Central Admixture Pharmacy Services, Inc.Equipment and facility · Material and supplier control · Aseptic processing and sterility assurance 2022-06-24 5 findings Hybrid Pharma, LLCAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls · Training and personnel · Validation and qualification 2022-06-14 6 findings Central Admixture Pharmacy Services, Inc.Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Computer system validation · Laboratory and QC controls · Equipment and facility 2022-06-13 6 findings Rentschler Biopharma SEMaterial and supplier control · Other quality system · Laboratory and QC controls · Equipment and facility 2022-06-10 7 findings Bioiberica, S.A.UOther quality system · Cleaning validation · Stability and storage · Quality unit oversight · Deviation, CAPA, and investigation 2022-06-09 5 findings Aire-Master of America, Inc.Equipment and facility · Complaint and recall handling · Laboratory and QC controls 2022-06-07 4 findings Nephron Sterile Compounding Center LLCRegulatory reporting and change control · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2022-06-03 7 findings CFP Acquisitions, IncOther quality system · Aseptic processing and sterility assurance · Material and supplier control · Environmental monitoring 2022-05-31 5 findings Hybrid Pharma LLCRegulatory reporting and change control · Laboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2022-05-31 7 findings BPI Labs LLCOther quality system · Equipment and facility · Material and supplier control 2022-05-31 3 findings OsteoLife Biomedical I LLCDeviation, CAPA, and investigation · Environmental monitoring · Process validation · Stability and storage 2022-05-31 4 findings New Vitalis, LLC dba New Vitalis PharmacyEquipment and facility · Training and personnel · Contamination control · Aseptic processing and sterility assurance · Environmental monitoring · Material and supplier control 2022-05-31 7 findings Crosbys Drugs IncEquipment and facility · Other quality system · Training and personnel · Aseptic processing and sterility assurance 2022-05-26 8 findings Aurobindo Pharma Ltd.Deviation, CAPA, and investigation · Stability and storage · Documentation and records · Computer system validation · Equipment and facility 2022-05-24 5 findings Specialty Process Labs LLCQuality unit oversight · Laboratory and QC controls · Computer system validation 2022-05-17 5 findings Colorful Products CorporationQuality unit oversight · Equipment and facility · Process validation · Computer system validation 2022-05-17 4 findings Novel Laboratories Inc. d.b.a. Lupin SomersetEquipment and facility · Laboratory and QC controls · Computer system validation · Other quality system · Complaint and recall handling · Quality unit oversight · Training and personnel · Deviation, CAPA, and investigation 2022-05-16 12 findings Sun Pharmaceutical Industries Ltd.Aseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation · Quality unit oversight · Training and personnel 2022-05-13 10 findings Apollo Care, LLCAseptic processing and sterility assurance 2022-05-13 3 findings Qualgen LLCEquipment and facility · Documentation and records · Labeling and packaging · Aseptic processing and sterility assurance 2022-05-05 7 findings The W.S. Badger Company, Inc.Laboratory and QC controls · Deviation, CAPA, and investigation · Process validation 2022-05-03 3 findings Froggy’s Fog LLCLaboratory and QC controls · Cleaning validation · Material and supplier control 2022-05-03 4 findings Age Management Institute Santa BarbaraAseptic processing and sterility assurance · Material and supplier control 2022-05-03 3 findings Fresh Farms LLCLaboratory and QC controls · Quality unit oversight · Documentation and records 2022-04-26 4 findings Clinical Resolution Laboratory Inc.Quality unit oversight · Equipment and facility · Process validation 2022-04-26 4 findings Vitae Enim Vitae Scientific Inc.Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight 2022-04-26 4 findings Wedgewood Connect, LLCAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Quality unit oversight 2022-04-22 4 findings Vi-Jon, LLCQuality unit oversight · Complaint and recall handling · Laboratory and QC controls 2022-04-19 3 findings "Daniel C. Tarquinio, D.O./Center for Rare Neurological DiseasesOther quality system 2022-04-19 3 findings Hiers Enterprises, LLC dba Northwest Compounding PharmacyContamination control 2022-04-15 3 findings Family Dollar Distribution Inc.Other quality system · Quality unit oversight · Contamination control · Equipment and facility · Stability and storage 2022-04-15 12 findings Generitech CorporationDeviation, CAPA, and investigation · Equipment and facility · Process validation · Material and supplier control 2022-04-12 4 findings Ultra Seal CorporationDeviation, CAPA, and investigation · Computer system validation 2022-04-12 3 findings Yusef Manufacturing Laboratories, LLCStability and storage · Process validation · Deviation, CAPA, and investigation · Material and supplier control · Laboratory and QC controls 2022-04-12 5 findings Med Shop Total Care, Inc.Aseptic processing and sterility assurance · Contamination control 2022-04-12 6 findings Zhejiang Hisun PharmaceuticalsProcess validation · Equipment and facility · Laboratory and QC controls · Stability and storage 2022-03-29 4 findings Agropharma Laboratories, Inc.Deviation, CAPA, and investigation · Process validation · Quality unit oversight 2022-03-29 3 findings Dr Retter Ec Wladyslaw RetterMaterial and supplier control · Laboratory and QC controls · Documentation and records 2022-03-29 3 findings Premier Trends LLCValidation and qualification · Material and supplier control · Documentation and records · Quality unit oversight · Equipment and facility 2022-03-22 5 findings Cadila Healthcare LimitedEquipment and facility · Quality unit oversight · Stability and storage 2022-03-18 3 findings LEESAR, INCDeviation, CAPA, and investigation · Documentation and records · Labeling and packaging · Material and supplier control · Regulatory reporting and change control 2022-03-16 5 findings Wuxi BiologicsQuality unit oversight · Deviation, CAPA, and investigation · Material and supplier control · Computer system validation · Equipment and facility 2022-03-15 6 findings Wuxi BiologicsOther quality system · Quality unit oversight · Aseptic processing and sterility assurance 2022-03-15 4 findings The Compounding PharmacyAseptic processing and sterility assurance · Equipment and facility 2022-03-14 3 findings Valgene Incorporated dba Cape DrugsEquipment and facility · Validation and qualification · Aseptic processing and sterility assurance · Other quality system 2022-03-09 4 findings New Vitalis Pharmacy LLC dba New Vitalis PharmacyContamination control · Equipment and facility · Training and personnel · Aseptic processing and sterility assurance 2022-03-09 7 findings SterRx, LLCContamination control · Laboratory and QC controls · Equipment and facility · Complaint and recall handling · Aseptic processing and sterility assurance · Training and personnel 2022-03-02 11 findings Smart Surgical, Inc dba Burst BiologicsOther quality system · Aseptic processing and sterility assurance · Quality unit oversight 2022-02-22 5 findings Denver Solutions, LLC OBA Leiters HealthLaboratory and QC controls · Deviation, CAPA, and investigation · Material and supplier control · Aseptic processing and sterility assurance 2022-02-18 7 findings Edge Pharma, LLCDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility · Labeling and packaging · Stability and storage · Computer system validation · Quality unit oversight 2022-02-18 13 findings Indiana Chem-PortLaboratory and QC controls · Regulatory reporting and change control · Documentation and records · Cleaning validation 2022-02-15 5 findings Richard J. Obiso, PhD dba Avila Herbals, LLCDeviation, CAPA, and investigation · Other quality system 2022-02-15 4 findings Innoveix Pharmaceuticals IncAseptic processing and sterility assurance 2022-02-08 9 findings Vita Pharmacy, LLC dba Talon Pharmacy of BoerneValidation and qualification · Aseptic processing and sterility assurance · Equipment and facility · Cleaning validation · Other quality system 2022-02-04 6 findings Johnson Memorial Cancer CenterContamination control · Aseptic processing and sterility assurance 2022-01-28 4 findings Health Plus Inc.Deviation, CAPA, and investigation · Quality unit oversight · Stability and storage · Laboratory and QC controls 2022-01-25 5 findings Intratheca l Compounding Specialists, LLCOther quality system · Aseptic processing and sterility assurance 2022-01-18 3 findings Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription ShopOther quality system · Equipment and facility 2022-01-18 5 findings Sunstar Americas, Inc.Laboratory and QC controls · Equipment and facility · Other quality system · Deviation, CAPA, and investigation · Quality unit oversight 2022-01-18 6 findings Catalent BrusselsEquipment and facility · Other quality system · Laboratory and QC controls 2022-01-14 3 findings Hubei Kangzheng Pharmaceutical Co., Ltd.Stability and storage · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Cleaning validation 2022-01-11 4 findings SSM Health Care St. Louis DBA SSM St. Clare Health CenterDeviation, CAPA, and investigation · Material and supplier control · Labeling and packaging · Aseptic processing and sterility assurance 2022-01-07 4 findings Eagle Pharmacy, Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation · Documentation and records 2022-01-07 6 findings Med Shop Total Care Inc.Aseptic processing and sterility assurance · Other quality system · Equipment and facility · Contamination control 2022-01-07 7 findings TAILSTORM HEALTH INCEquipment and facility · Cleaning validation · Labeling and packaging · Laboratory and QC controls · Deviation, CAPA, and investigation 2022-01-07 5 findings