US FDA · 2025

Pharmathen International S.A.Laboratory and QC controls · Process validation · Aseptic processing and sterility assurance · Contamination control · Equipment and facility · Deviation, CAPA, and investigation 2025-12-29 9 findings Sun Pharmaceuticals Medicare Ltd.Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2025-12-29 3 findings Revive Rx LLC dba Revive Rx PharmacyDeviation, CAPA, and investigation · Contamination control · Aseptic processing and sterility assurance · Environmental monitoring 2025-12-23 12 findings Medinatura New Mexico, Inc.Material and supplier control · Cleaning validation · Process validation 2025-12-23 3 findings Darmerica, LLCOther quality system · Material and supplier control · Complaint and recall handling 2025-12-23 6 findings UBI Pharma Inc.Deviation, CAPA, and investigation · Quality unit oversight · Equipment and facility · Aseptic processing and sterility assurance · Material and supplier control 2025-12-18 5 findings Empower Clinic Services LLC dba Empower PharmacyEquipment and facility · Contamination control · Training and personnel · Aseptic processing and sterility assurance 2025-12-18 5 findings TAILSTORM HEALTH INCLaboratory and QC controls · Equipment and facility 2025-12-18 3 findings SCA Pharmaceuticals IncAseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation 2025-12-18 3 findings Sklar Personal Care Inc.Process validation · Cleaning validation · Quality unit oversight · Material and supplier control 2025-12-16 4 findings 3D Imaging Drug Design and Development LLCEquipment and facility · Aseptic processing and sterility assurance 2025-12-16 3 findings Catalent Indiana LLCAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight · Process validation · Material and supplier control 2025-12-15 6 findings ProRx LLCAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Labeling and packaging · Laboratory and QC controls 2025-12-15 7 findings Seaway Pharma Inc.Process validation · Quality unit oversight · Material and supplier control 2025-12-09 3 findings DeVere Manufacturing Inc.Equipment and facility · Material and supplier control · Quality unit oversight 2025-12-09 3 findings CDL Services, Inc. DBA TechnichemQuality unit oversight · Material and supplier control · Laboratory and QC controls 2025-12-09 3 findings Park Avenue CompoundingAseptic processing and sterility assurance · Quality unit oversight · Computer system validation · Equipment and facility 2025-12-08 7 findings Central Admixture Pharmacy Services IncLaboratory and QC controls · Material and supplier control · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2025-12-03 4 findings Apotex Inc.Deviation, CAPA, and investigation · Material and supplier control · Computer system validation · Aseptic processing and sterility assurance · Equipment and facility · Process validation · Laboratory and QC controls · Complaint and recall handling 2025-12-02 10 findings Farmakeio Outsourcing LLCLaboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation 2025-12-02 5 findings PQ Pharmacy, LLCDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Process validation · Validation and qualification · Equipment and facility 2025-12-02 13 findings Turbare ManufacturingAseptic processing and sterility assurance · Quality unit oversight · Deviation, CAPA, and investigation 2025-12-02 9 findings Central Admixture Pharmacy Services IncDeviation, CAPA, and investigation · Material and supplier control · Laboratory and QC controls · Aseptic processing and sterility assurance · Quality unit oversight 2025-12-01 7 findings Owen Biosciences, Inc.Stability and storage · Laboratory and QC controls · Quality unit oversight 2025-11-25 3 findings Wells Pharma of Houston, LLCCleaning validation · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Material and supplier control · Quality unit oversight · Environmental monitoring · Equipment and facility · Labeling and packaging 2025-11-25 25 findings Molecular PharmaGroup LLCAseptic processing and sterility assurance · Quality unit oversight 2025-11-24 3 findings Fareva AmboiseComputer system validation · Aseptic processing and sterility assurance · Documentation and records · Equipment and facility · Process validation 2025-11-21 9 findings Immacule Lifesciences Private LimitedAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Computer system validation · Equipment and facility 2025-11-21 6 findings Seema InternationalDocumentation and records · Cleaning validation · Deviation, CAPA, and investigation 2025-11-18 3 findings DermaRite Industries, LLCDeviation, CAPA, and investigation · Material and supplier control · Quality unit oversight · Stability and storage 2025-11-18 4 findings Uriel Pharmacy, Inc.Material and supplier control · Laboratory and QC controls · Quality unit oversight 2025-11-18 4 findings Siddha Flower Essences, LLC., dba Siddha RemediesLaboratory and QC controls · Deviation, CAPA, and investigation · Documentation and records 2025-11-18 3 findings NerPharMa S.r.l.Laboratory and QC controls · Computer system validation · Process validation · Aseptic processing and sterility assurance · Quality unit oversight · Deviation, CAPA, and investigation 2025-11-17 8 findings Baxter Oncology GmbHValidation and qualification · Equipment and facility · Other quality system · Stability and storage 2025-11-05 5 findings Alvotech HfAseptic processing and sterility assurance · Quality unit oversight · Equipment and facility · Material and supplier control · Documentation and records · Laboratory and QC controls · Deviation, CAPA, and investigation · Process validation · Computer system validation 2025-11-05 10 findings Kath Khemicals LLCLaboratory and QC controls · Stability and storage · Complaint and recall handling 2025-11-04 4 findings Apotex Inc.Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation 2025-11-04 3 findings Alembic Pharmaceuticals Limited Units I & IILaboratory and QC controls · Deviation, CAPA, and investigation · Equipment and facility · Quality unit oversight 2025-11-03 4 findings Zydus Lifesciences LimitedLaboratory and QC controls · Quality unit oversight · Equipment and facility · Complaint and recall handling 2025-10-30 4 findings The Tranzonic Companies/Innocore Sales & Marketing Inc.Laboratory and QC controls · Stability and storage · Quality unit oversight · Material and supplier control 2025-10-28 4 findings Dr. Reddy's LaboratoriesDeviation, CAPA, and investigation · Quality unit oversight · Equipment and facility 2025-10-27 4 findings Sumitomo Pharma Co., Ltd.Computer system validation · Contamination control · Other quality system 2025-10-24 3 findings BRS Analytical Services, LLCAseptic processing and sterility assurance 2025-10-21 3 findings Foshan Yiying Hygiene Products Co., Ltd.Stability and storage · Process validation · Laboratory and QC controls · Documentation and records · Material and supplier control 2025-10-21 5 findings Guangxi Yulin Pharmaceutical Group Co. Ltd.Laboratory and QC controls · Computer system validation · Stability and storage 2025-10-21 4 findings Lupin Limited Unit-3Process validation · Material and supplier control · Other quality system 2025-10-15 3 findings Health and Natural Beauty USA Corp.Material and supplier control · Quality unit oversight · Process validation 2025-10-14 3 findings Naturich Cosmetique LabsDeviation, CAPA, and investigation · Process validation · Material and supplier control 2025-10-07 3 findings Dixon Investments Inc. dba ARIQuality unit oversight · Stability and storage · Process validation 2025-10-07 3 findings Creative Essences, Inc.Laboratory and QC controls · Material and supplier control · Quality unit oversight · Process validation · Deviation, CAPA, and investigation 2025-10-07 5 findings Aurobindo Pharma Ltd. Unit-XIIAseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Process validation · Deviation, CAPA, and investigation 2025-10-03 7 findings Dr. Reddy’s Laboratories, LTD, BiologicsOther quality system · Environmental monitoring · Contamination control 2025-10-01 4 findings Persōn & Covey, Inc.Deviation, CAPA, and investigation · Quality unit oversight · Process validation 2025-09-30 4 findings Brands International CorporationStability and storage · Laboratory and QC controls · Quality unit oversight · Equipment and facility · Material and supplier control · Training and personnel · Complaint and recall handling · Process validation · Deviation, CAPA, and investigation · Other quality system · Documentation and records 2025-09-26 19 findings Cohance Lifesciences LimitedLaboratory and QC controls · Complaint and recall handling · Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation 2025-09-22 6 findings Nephron Sc IncQuality unit oversight · Aseptic processing and sterility assurance · Process validation · Material and supplier control 2025-09-22 6 findings RC Outsourcing LLCDeviation, CAPA, and investigation · Documentation and records · Equipment and facility · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls 2025-09-22 8 findings Fagron Compounding ServicesDeviation, CAPA, and investigation · Validation and qualification · Equipment and facility · Aseptic processing and sterility assurance 2025-09-18 6 findings Lupin Limited Unit 2Aseptic processing and sterility assurance · Material and supplier control · Deviation, CAPA, and investigation 2025-09-16 4 findings Somerset Therapeutics Private LimitedAseptic processing and sterility assurance · Deviation, CAPA, and investigation 2025-09-16 3 findings Columbia Cosmetics Manufacturing Inc.Process validation · Deviation, CAPA, and investigation · Material and supplier control 2025-09-16 3 findings Yangzhou Yulou Paper Products Co., Ltd.Stability and storage · Material and supplier control · Quality unit oversight · Aseptic processing and sterility assurance · Process validation 2025-09-16 5 findings Olympia PharmaceuticalsProcess validation · Aseptic processing and sterility assurance 2025-09-12 3 findings GenoGenix, LLCAseptic processing and sterility assurance · Material and supplier control · Regulatory reporting and change control · Quality unit oversight · Other quality system · Labeling and packaging · Documentation and records · Process validation · Laboratory and QC controls · Training and personnel · Equipment and facility · Deviation, CAPA, and investigation 2025-09-04 16 findings AnazaoHealth CorporationAseptic processing and sterility assurance · Complaint and recall handling · Process validation · Laboratory and QC controls 2025-09-02 4 findings Chromatography Institute of America dba Compounder’s International Analytical LaboratoryLaboratory and QC controls · Computer system validation · Aseptic processing and sterility assurance 2025-09-02 3 findings Wisconsin Pharmacal Company, LLCComputer system validation · Quality unit oversight · Deviation, CAPA, and investigation 2025-09-02 3 findings IntegraDose Compounding Services LLCTraining and personnel · Aseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight 2025-08-28 5 findings Hikma Injectables USA Inc.Equipment and facility · Process validation · Aseptic processing and sterility assurance 2025-08-27 3 findings Anhui Hanbon Daily Chemical Co., Ltd.Material and supplier control · Process validation · Laboratory and QC controls · Stability and storage 2025-08-19 4 findings Everlaan Organics, Inc. dba Maple OrganicsQuality unit oversight · Material and supplier control · Documentation and records · Laboratory and QC controls 2025-08-19 4 findings BSO, LLCProcess validation · Training and personnel · Laboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage 2025-08-14 7 findings BSO, LLCEquipment and facility · Laboratory and QC controls · Process validation · Documentation and records · Aseptic processing and sterility assurance 2025-08-12 8 findings ABBE Laboratories, Inc.Complaint and recall handling · Cleaning validation · Material and supplier control · Process validation 2025-08-12 4 findings Right Value Drug Stores, LLCAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Process validation · Documentation and records 2025-08-11 5 findings Stokes Healthcare Inc. dba Epicur PharmaAseptic processing and sterility assurance · Laboratory and QC controls · Process validation · Stability and storage 2025-08-11 5 findings Wedgewood Connect, LLCAseptic processing and sterility assurance · Process validation · Stability and storage · Training and personnel 2025-08-08 5 findings Dr. Reddy's Laboratories LimitedAseptic processing and sterility assurance · Other quality system · Equipment and facility · Material and supplier control · Quality unit oversight · Deviation, CAPA, and investigation 2025-08-07 6 findings Medi-Fare Drug Pharmaceutical Compounding LLCAseptic processing and sterility assurance · Process validation · Contamination control · Deviation, CAPA, and investigation · Training and personnel · Stability and storage · Material and supplier control 2025-08-07 9 findings TAILSTORM HEALTH INCEquipment and facility · Contamination control · Quality unit oversight · Deviation, CAPA, and investigation 2025-08-07 5 findings Boothwyn Pharmacy LLCOther quality system · Aseptic processing and sterility assurance · Equipment and facility 2025-08-07 5 findings Oasis Medical, Inc.Quality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance 2025-08-05 4 findings Jubilant HollisterStier General PartnershipMaterial and supplier control · Equipment and facility · Other quality system · Aseptic processing and sterility assurance · Laboratory and QC controls · Documentation and records · Complaint and recall handling 2025-07-31 12 findings Apollo Care LLCQuality unit oversight · Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation 2025-07-31 5 findings Kabana Skin Care LLCMaterial and supplier control · Laboratory and QC controls · Quality unit oversight 2025-07-29 3 findings Nature’s Fusions LLCLaboratory and QC controls · Material and supplier control · Equipment and facility · Process validation 2025-07-22 4 findings Medical Chemical CorporationQuality unit oversight · Material and supplier control · Process validation 2025-07-22 3 findings Glenmark Pharmaceuticals LimitedLaboratory and QC controls · Deviation, CAPA, and investigation · Stability and storage 2025-07-22 3 findings Daewoo Pharmaceutical Co., Ltd.Cleaning validation · Aseptic processing and sterility assurance · Process validation · Quality unit oversight 2025-07-15 5 findings Natco Pharma LimitedAseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation 2025-07-10 6 findings Sun Pharmaceutical Industries Ltd.Laboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Process validation · Documentation and records 2025-07-09 8 findings Xtreme Tools International, Inc.Process validation · Quality unit oversight · Laboratory and QC controls 2025-07-08 3 findings Exela Pharma Sciences, LLCDeviation, CAPA, and investigation · Training and personnel · Laboratory and QC controls · Quality unit oversight · Aseptic processing and sterility assurance · Stability and storage · Process validation 2025-07-03 11 findings Staska Pharmaceuticals, Inc.Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Validation and qualification · Process validation · Training and personnel · Documentation and records 2025-07-01 17 findings Caraco Pharmaceutical Laboratories, Ltd.Material and supplier control · Deviation, CAPA, and investigation · Equipment and facility · Training and personnel · Process validation · Quality unit oversight · Documentation and records · Other quality system 2025-06-30 14 findings Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. SirketiMaterial and supplier control · Quality unit oversight · Laboratory and QC controls 2025-06-24 3 findings LeeSar, Inc.Deviation, CAPA, and investigation · Quality unit oversight · Process validation 2025-06-23 4 findings STAQ Pharma of Ohio, LLCLabeling and packaging · Process validation · Material and supplier control 2025-06-23 3 findings New England Home Therapies, Inc.Training and personnel · Complaint and recall handling · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility 2025-06-20 8 findings Essential Pharmacy Compounding LLCValidation and qualification · Aseptic processing and sterility assurance · Complaint and recall handling · Laboratory and QC controls · Equipment and facility · Material and supplier control · Training and personnel · Stability and storage · Deviation, CAPA, and investigation 2025-06-20 12 findings Hunter Holmes McGuire Veterans Affairs Medical CenterAseptic processing and sterility assurance · Other quality system 2025-06-20 3 findings Meridian Medical Technologies, Inc.Other quality system · Quality unit oversight · Process validation · Validation and qualification 2025-06-20 7 findings Central Admixture Pharmacy Services, Inc.Equipment and facility · Material and supplier control · Quality unit oversight · Other quality system 2025-06-20 6 findings Unico Holdings, Inc.Material and supplier control · Other quality system · Equipment and facility · Labeling and packaging · Contamination control · Training and personnel 2025-06-20 19 findings Caraco Pharmaceutical Laboratories, Ltd.Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Material and supplier control · Training and personnel · Process validation · Complaint and recall handling · Documentation and records 2025-06-20 14 findings Laboratorios Farmaceuticos Rovi S. A.Laboratory and QC controls · Process validation · Aseptic processing and sterility assurance · Quality unit oversight 2025-06-20 6 findings Advanced Nutriceuticals, LLCMaterial and supplier control · Other quality system · Aseptic processing and sterility assurance · Training and personnel · Equipment and facility · Contamination control 2025-06-20 10 findings Biocon Sdn. Bhd.Aseptic processing and sterility assurance · Documentation and records · Computer system validation · Deviation, CAPA, and investigation · Other quality system 2025-06-20 7 findings Revance Therapeutics, Inc.Equipment and facility · Deviation, CAPA, and investigation · Other quality system 2025-06-20 3 findings Ideal Specialty Apothecary, Inc. dba Ideal PharmacyValidation and qualification · Aseptic processing and sterility assurance · Equipment and facility 2025-06-20 4 findings Fusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalLaboratory and QC controls · Labeling and packaging · Aseptic processing and sterility assurance · Regulatory reporting and change control 2025-06-20 6 findings Fusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalRegulatory reporting and change control · Aseptic processing and sterility assurance · Laboratory and QC controls · Labeling and packaging 2025-06-20 8 findings Fusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalRegulatory reporting and change control · Laboratory and QC controls · Aseptic processing and sterility assurance · Labeling and packaging 2025-06-20 8 findings Akorn, Inc.Laboratory and QC controls · Process validation · Deviation, CAPA, and investigation · Quality unit oversight 2025-06-20 6 findings Kenil Healthcare Private LimitedEquipment and facility · Quality unit oversight 2025-06-17 3 findings Horizon Tool Inc.Documentation and records · Material and supplier control · Stability and storage 2025-06-17 3 findings Zhejiang Huahai Pharmaceutical Co., Ltd.Aseptic processing and sterility assurance · Process validation · Cleaning validation 2025-06-17 3 findings Laboratoire Druide Inc.Material and supplier control · Cleaning validation · Process validation 2025-06-10 3 findings Amish Origins Management, LLCQuality unit oversight · Material and supplier control · Documentation and records 2025-06-10 3 findings Amy Lightner, MDDeviation, CAPA, and investigation · Other quality system 2025-06-03 3 findings CTK OTC Laboratories LLC formerly FMK LABS, Inc.Laboratory and QC controls · Process validation · Deviation, CAPA, and investigation 2025-06-03 3 findings Zhejiang Easyclean Daily Chemical Co., LtdProcess validation · Stability and storage · Documentation and records 2025-06-03 3 findings Evi Labs LLCQuality unit oversight · Laboratory and QC controls 2025-06-03 4 findings Rechon Life Science ABEnvironmental monitoring · Aseptic processing and sterility assurance 2025-06-03 4 findings Apothecary Pharma LLCAseptic processing and sterility assurance · Quality unit oversight · Contamination control · Regulatory reporting and change control · Documentation and records 2025-06-02 8 findings East Orange VA Medical CenterEquipment and facility · Other quality system · Contamination control 2025-06-02 3 findings Symrise, S. de R.L de C.V.Process validation · Documentation and records · Laboratory and QC controls · Quality unit oversight 2025-05-28 5 findings Zhejiang Huahai Pharmaceutical Co., Ltd.Aseptic processing and sterility assurance · Process validation · Quality unit oversight · Laboratory and QC controls · Equipment and facility 2025-05-23 6 findings Sanofi-Aventis Deutschland GmbHAseptic processing and sterility assurance · Cleaning validation · Other quality system 2025-05-23 3 findings Aurolife Pharma LLCProcess validation · Equipment and facility · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Regulatory reporting and change control 2025-05-23 10 findings Suzhou Suncadia Biopharmaceuticals Co., Ltd.Aseptic processing and sterility assurance · Other quality system · Equipment and facility 2025-05-23 3 findings Skye Biologics Holdings LLCAseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls · Process validation · Documentation and records 2025-05-20 7 findings Product Society LLCMaterial and supplier control · Process validation · Quality unit oversight 2025-05-20 3 findings NWL Netherlands Services B.V.Deviation, CAPA, and investigation · Computer system validation · Material and supplier control 2025-05-20 3 findings Wuxi Medical Instrument Factory Co., Ltd.Aseptic processing and sterility assurance · Material and supplier control 2025-05-20 3 findings Ningbo Riway Industrial Co., Ltd.Quality unit oversight · Material and supplier control · Laboratory and QC controls 2025-05-13 3 findings Mentha & Allied Products Private Ltd.Process validation · Laboratory and QC controls · Documentation and records · Material and supplier control · Equipment and facility 2025-05-13 5 findings BioAsia Worldwide Sdn BhdLaboratory and QC controls · Material and supplier control · Process validation · Quality unit oversight 2025-05-13 4 findings Tailstorm Health Inc. dba Medivant HealthAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility 2025-05-13 8 findings OSRX, Inc.Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Process validation · Documentation and records · Validation and qualification · Training and personnel · Environmental monitoring 2025-05-13 20 findings Excelvision FarevaAseptic processing and sterility assurance 2025-05-13 3 findings Shantou S.E.Z. Baojie Industry Co., Ltd.Quality unit oversight · Stability and storage · Material and supplier control · Process validation 2025-05-13 4 findings Wells Pharma of Houston LLCDeviation, CAPA, and investigation · Quality unit oversight · Labeling and packaging · Regulatory reporting and change control · Aseptic processing and sterility assurance · Equipment and facility 2025-05-07 8 findings PQ Pharmacy LLCProcess validation · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2025-05-07 4 findings QuVa Pharma, Inc.Training and personnel · Laboratory and QC controls · Deviation, CAPA, and investigation · Other quality system 2025-05-07 5 findings Thrive Health and Wellness LLCAseptic processing and sterility assurance · Other quality system · Equipment and facility 2025-05-07 6 findings Cosco International, Inc.Laboratory and QC controls · Process validation · Stability and storage · Quality unit oversight 2025-04-29 4 findings Empower Clinic Services, LLC dba Empower PharmacyEquipment and facility · Aseptic processing and sterility assurance · Environmental monitoring 2025-04-29 6 findings Dyno Manufacturing, Inc.Stability and storage · Quality unit oversight · Process validation · Material and supplier control 2025-04-29 4 findings BEO Pharma Inc. dba BEO Pharmaceuticals Inc.Material and supplier control · Process validation · Quality unit oversight · Laboratory and QC controls 2025-04-29 4 findings Empower Clinic Services, LLC dba Empower PharmaDeviation, CAPA, and investigation · Cleaning validation · Aseptic processing and sterility assurance · Process validation 2025-04-22 13 findings PMS4PMS, LLCQuality unit oversight · Laboratory and QC controls · Stability and storage 2025-04-15 3 findings Nubratori, Inc. dba Nubratori RxOther quality system · Material and supplier control · Environmental monitoring · Aseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Documentation and records 2025-04-15 13 findings Suzhou Suncadia Biopharmaceutical CO., Ltd.Other quality system · Laboratory and QC controls · Quality unit oversight · Aseptic processing and sterility assurance · Data integrity 2025-03-28 8 findings Palmetto Isotopes LLCAseptic processing and sterility assurance · Environmental monitoring · Equipment and facility 2025-03-28 6 findings SKNVContamination control · Labeling and packaging · Deviation, CAPA, and investigation 2025-03-28 3 findings Eagle Pharma Outsourcing LLCAseptic processing and sterility assurance · Contamination control · Equipment and facility 2025-03-28 4 findings Revive Rx LLCContamination control · Aseptic processing and sterility assurance · Environmental monitoring · Equipment and facility 2025-03-28 7 findings Aspen Biopharma Labs Private LimitedProcess validation · Stability and storage · Equipment and facility · Data integrity 2025-03-25 4 findings Annovex Pharma, Inc.Material and supplier control · Aseptic processing and sterility assurance · Computer system validation · Deviation, CAPA, and investigation · Documentation and records · Equipment and facility 2025-03-25 11 findings Hangzhou Glamcos Biotech Co., Ltd.Stability and storage · Documentation and records · Material and supplier control 2025-03-25 3 findings Yangzhou Sion Commodity Co., Ltd.Material and supplier control · Quality unit oversight · Laboratory and QC controls 2025-03-25 3 findings Eli Lilly and CompanyEquipment and facility · Process validation · Laboratory and QC controls 2025-03-24 3 findings Bushu Pharmaceuticals Ltd.Quality unit oversight · Contamination control · Laboratory and QC controls 2025-03-24 3 findings Rite-Kem IncorporatedQuality unit oversight · Laboratory and QC controls · Material and supplier control 2025-03-18 3 findings Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim SirketiMaterial and supplier control · Stability and storage · Quality unit oversight · Process validation 2025-03-18 4 findings Aspen Pharmacare Holdings LimitedAseptic processing and sterility assurance · Data integrity 2025-03-18 4 findings International Laboratories CorpQuality unit oversight · Laboratory and QC controls · Computer system validation 2025-03-18 3 findings Advanced Pharmaceutical TechnologyAseptic processing and sterility assurance · Quality unit oversight · Laboratory and QC controls 2025-03-18 4 findings MedisourceRxDeviation, CAPA, and investigation · Material and supplier control · Equipment and facility · Aseptic processing and sterility assurance · Documentation and records · Process validation 2025-03-11 7 findings Right Value Drug Stores, LLC dba Carie Boyd PharmaceuticalsEquipment and facility · Aseptic processing and sterility assurance · Documentation and records · Deviation, CAPA, and investigation · Process validation 2025-03-11 14 findings Linghai ZhanWang Biotechnology Co., LtdMaterial and supplier control · Quality unit oversight · Stability and storage 2025-03-11 3 findings Shree Jaya Laboratories PVT. LTD.Documentation and records · Complaint and recall handling · Cleaning validation 2025-03-11 3 findings Dr. Reddy's Laboratories Ltd., BiologicsOther quality system · Cleaning validation · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2025-03-06 9 findings Glenmark Pharmaceuticals Ltd.Deviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility 2025-03-06 3 findings Piramal, Piramal Pharma LimitedQuality unit oversight · Equipment and facility · Deviation, CAPA, and investigation · Complaint and recall handling · Documentation and records 2025-03-06 5 findings Fuji Yakuhin Co., Ltd.Equipment and facility · Aseptic processing and sterility assurance · Other quality system 2025-03-06 3 findings Oishi Koseido Co., Ltd.Laboratory and QC controls · Other quality system · Equipment and facility · Material and supplier control · Stability and storage 2025-03-06 6 findings Kyowa Hakko Bio Co., Ltd.Other quality system · Material and supplier control · Laboratory and QC controls 2025-03-06 3 findings Indoco Remedies LimitedMaterial and supplier control · Quality unit oversight · Aseptic processing and sterility assurance · Complaint and recall handling 2025-03-06 5 findings Amman Pharmaceutical IndustriesEquipment and facility · Laboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Documentation and records · Quality unit oversight 2025-03-06 10 findings Daizo CorporationLaboratory and QC controls · Computer system validation 2025-03-06 3 findings Hanlim Pharm Co., Ltd.Other quality system · Laboratory and QC controls · Aseptic processing and sterility assurance 2025-03-06 6 findings Janssen Vaccines CorporationAseptic processing and sterility assurance · Quality unit oversight · Equipment and facility 2025-03-06 5 findings Zhejiang Huahai Pharmaceutical Co., Ltd.Documentation and records · Deviation, CAPA, and investigation · Equipment and facility · Quality unit oversight 2025-03-06 4 findings Wuxi Biologics Co., Ltd.Equipment and facility · Aseptic processing and sterility assurance · Other quality system · Process validation · Quality unit oversight 2025-03-06 5 findings ProRx, LLCOther quality system · Equipment and facility · Environmental monitoring · Stability and storage · Contamination control · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Documentation and records · Material and supplier control · Quality unit oversight 2025-03-04 34 findings Chem-Tech, Ltd.Complaint and recall handling · Deviation, CAPA, and investigation · Equipment and facility 2025-03-04 3 findings Granules India LimitedEquipment and facility 2025-03-04 3 findings Carolina InfusionAseptic processing and sterility assurance · Contamination control · Material and supplier control · Environmental monitoring · Other quality system 2025-02-28 6 findings Compounded Solutions in PharmacyAseptic processing and sterility assurance · Material and supplier control · Contamination control · Environmental monitoring 2025-02-27 9 findings CMC Enterprise PharmacyAseptic processing and sterility assurance · Training and personnel · Equipment and facility 2025-02-19 8 findings AmWiner & Raphe Holdings, LLC dba rapheGenerics CorpQuality unit oversight · Laboratory and QC controls · Material and supplier control 2025-02-18 3 findings Tyche Industries LtdCleaning validation · Material and supplier control · Quality unit oversight 2025-02-18 3 findings Exela Pharma Sciences LLCQuality unit oversight · Laboratory and QC controls · Material and supplier control · Deviation, CAPA, and investigation · Equipment and facility · Computer system validation · Training and personnel · Process validation · Stability and storage · Aseptic processing and sterility assurance 2025-02-14 13 findings Pine Pharmaceuticals, LLCAseptic processing and sterility assurance · Material and supplier control · Labeling and packaging · Process validation · Contamination control 2025-02-12 9 findings Boothwyn Pharmacy LLCMaterial and supplier control · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls · Quality unit oversight 2025-02-12 5 findings Wuhu Nuowei Chemistry Co., Ltd.Laboratory and QC controls · Cleaning validation · Quality unit oversight 2025-02-11 3 findings Strukmyer LLC dba Strukmyer MedicalQuality unit oversight · Material and supplier control · Deviation, CAPA, and investigation · Equipment and facility 2025-02-11 4 findings Turbare ManufacturingAseptic processing and sterility assurance · Laboratory and QC controls · Process validation · Quality unit oversight · Deviation, CAPA, and investigation · Training and personnel 2025-02-07 8 findings F.H. Investments Inc.Contamination control · Laboratory and QC controls · Deviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance 2025-02-07 5 findings Empower Clinic Services, LLCContamination control · Environmental monitoring · Equipment and facility · Aseptic processing and sterility assurance · Validation and qualification · Other quality system 2025-02-07 8 findings OurPharma LLCRegulatory reporting and change control · Aseptic processing and sterility assurance · Labeling and packaging · Process validation 2025-02-07 5 findings Overton Brooks VA Medical CenterContamination control · Aseptic processing and sterility assurance 2025-02-07 3 findings Global Calcium Pvt. LimitedDocumentation and records · Equipment and facility · Material and supplier control 2025-02-04 3 findings BioStem Life SciencesDocumentation and records · Laboratory and QC controls · Aseptic processing and sterility assurance · Process validation 2025-02-04 5 findings Fagron Compounding Services, LLC dba Fagron Sterile ServiceAseptic processing and sterility assurance · Labeling and packaging · Equipment and facility · Deviation, CAPA, and investigation 2025-02-04 10 findings Imperial Palace Commodity -Dongguan- Co., Ltd.Process validation · Material and supplier control · Quality unit oversight · Laboratory and QC controls 2025-02-04 4 findings Kardesler Ucan Yaglar Sanayi Anonim SirketiQuality unit oversight · Material and supplier control · Laboratory and QC controls 2025-01-28 3 findings SCA Pharmaceuticals LLCEquipment and facility · Aseptic processing and sterility assurance · Documentation and records · Process validation · Deviation, CAPA, and investigation 2025-01-21 7 findings INCELL Corporation LLCAseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage 2025-01-21 3 findings SanofiDeviation, CAPA, and investigation · Contamination control · Documentation and records · Equipment and facility 2025-01-21 5 findings QuVa Pharma IncProcess validation · Complaint and recall handling · Quality unit oversight · Aseptic processing and sterility assurance 2025-01-16 4 findings Indoco Remedies LimitedComplaint and recall handling · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight 2025-01-07 7 findings Mylan Laboratories Ltd.Quality unit oversight · Other quality system · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Computer system validation 2025-01-03 6 findings