US FDA · 2026

Loba biotech GmbHDeviation, CAPA, and investigation · Equipment and facility · Training and personnel · Validation and qualification · Other quality system 2026-10-19 6 findings Eugia Pharma Specialities LimitedQuality unit oversight · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls · Process validation · Equipment and facility 2026-10-19 9 findings Dendreon Pharmaceuticals LLCDocumentation and records · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Other quality system · Quality unit oversight · Process validation · Laboratory and QC controls 2026-10-19 9 findings Kansas State Veterinary Diagnostic LaboratoryProcess validation · Laboratory and QC controls · Equipment and facility · Documentation and records 2026-10-19 4 findings DiagastDocumentation and records · Stability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control · Other quality system 2026-10-19 6 findings Greer Laboratories, Inc.Equipment and facility · Quality unit oversight · Other quality system · Process validation 2026-10-19 5 findings Almon Healthcare Private LimitedQuality unit oversight · Material and supplier control · Other quality system · Cleaning validation · Computer system validation · Stability and storage · Equipment and facility · Laboratory and QC controls 2026-10-19 11 findings Centrient Pharmaceuticals India Private LimitedEquipment and facility · Material and supplier control · Cleaning validation 2026-10-19 3 findings Perrigo New York, Inc.Contamination control · Equipment and facility 2026-10-19 3 findings GPC Medical LimitedOther quality system · Laboratory and QC controls 2026-10-19 4 findings Zen Chemicals Pvt. LtdCleaning validation · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls 2026-10-19 5 findings Mylan Laboratories LimitedStability and storage · Computer system validation · Equipment and facility · Deviation, CAPA, and investigation · Complaint and recall handling · Quality unit oversight 2026-10-19 6 findings SCA Pharmaceuticals, LLCAseptic processing and sterility assurance · Material and supplier control · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Equipment and facility 2026-10-13 15 findings Jiangmen Shuizirun Sanitary Articles Co., Ltd.Quality unit oversight · Aseptic processing and sterility assurance · Material and supplier control 2026-10-13 3 findings Hanlim Pharm Co., Ltd.Aseptic processing and sterility assurance · Quality unit oversight · Process validation 2026-10-13 3 findings Lovelace Biomedical Research InstituteOther quality system 2026-10-13 4 findings Eurofins SF Analytical Laboratories, Inc.Deviation, CAPA, and investigation · Laboratory and QC controls · Quality unit oversight 2026-10-13 3 findings Imprimis NJOF LLCLaboratory and QC controls · Quality unit oversight · Deviation, CAPA, and investigation · Process validation 2026-10-06 4 findings RC Outsourcing LLCEquipment and facility · Stability and storage · Deviation, CAPA, and investigation · Contamination control · Laboratory and QC controls · Training and personnel · Aseptic processing and sterility assurance 2026-10-06 8 findings Pine Pharmaceuticals, LLCDocumentation and records · Aseptic processing and sterility assurance · Complaint and recall handling · Validation and qualification · Deviation, CAPA, and investigation · Other quality system · Process validation · Training and personnel 2026-10-06 13 findings TCI Co., Ltd BioCosme PABP BRANCHQuality unit oversight · Material and supplier control · Laboratory and QC controls · Process validation 2026-10-06 4 findings OPS International Inc dba Olympia PharmaceuticalsProcess validation · Material and supplier control · Aseptic processing and sterility assurance · Laboratory and QC controls 2026-10-01 8 findings Houston Rx LLCAseptic processing and sterility assurance · Other quality system · Stability and storage · Equipment and facility · Contamination control · Cleaning validation 2026-10-01 14 findings Right Value Drug Stores LLCDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Other quality system · Quality unit oversight · Laboratory and QC controls 2026-09-30 6 findings TAILSTORM HEALTH INCLaboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility 2026-09-29 5 findings Bentley Laboratories LLCMaterial and supplier control · Process validation 2026-09-29 3 findings VeganicSKN LimitedMaterial and supplier control · Quality unit oversight · Deviation, CAPA, and investigation 2026-09-29 3 findings Babikian Healthcare Products CJSCMaterial and supplier control · Laboratory and QC controls · Quality unit oversight 2026-09-29 3 findings Curia New York, Inc.Laboratory and QC controls · Computer system validation · Data integrity 2026-09-29 3 findings Stream2Sea, LLCMaterial and supplier control · Cleaning validation · Laboratory and QC controls 2026-09-29 3 findings IntegraDose Compounding Services LLCAseptic processing and sterility assurance · Quality unit oversight 2026-09-22 4 findings OurPharma LLCQuality unit oversight · Aseptic processing and sterility assurance 2026-09-22 3 findings STAQ Pharma of Ohio LLCAseptic processing and sterility assurance · Laboratory and QC controls · Documentation and records 2026-09-22 3 findings Carolina Infusion LLCOther quality system · Contamination control · Environmental monitoring · Aseptic processing and sterility assurance · Equipment and facility 2026-09-22 10 findings PQ Pharmacy LLCAseptic processing and sterility assurance · Quality unit oversight · Computer system validation · Equipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation 2026-09-22 7 findings kdc/one Chatsworth, Inc.Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls 2026-09-22 3 findings Empower Clinic Services, LLC dba Empower PharmacyQuality unit oversight · Aseptic processing and sterility assurance · Process validation 2026-09-22 7 findings NexCell Scientific IncAseptic processing and sterility assurance · Process validation · Laboratory and QC controls · Quality unit oversight 2026-09-22 7 findings Apollo Care LLCDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Material and supplier control · Regulatory reporting and change control · Equipment and facility · Quality unit oversight 2026-09-10 7 findings Brookfield Medical Surgical Supplies IncQuality unit oversight · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2026-09-10 3 findings CD Pharmacy LLC dba Red Rock PharmacyAseptic processing and sterility assurance · Other quality system · Material and supplier control · Contamination control 2026-09-10 9 findings XeCare LLCOther quality system · Contamination control · Material and supplier control 2026-09-10 3 findings Turbare ManufacturingQuality unit oversight · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Training and personnel 2026-09-08 4 findings Fayetteville VA Medical CenterEquipment and facility · Contamination control 2026-09-03 3 findings Jabil Inc.Aseptic processing and sterility assurance · Documentation and records 2026-09-01 3 findings R3 Medical CompaniesAseptic processing and sterility assurance · Process validation · Complaint and recall handling 2026-08-25 5 findings K.C. Pharmaceuticals, Inc.Documentation and records · Complaint and recall handling · Laboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2026-08-18 5 findings Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.Deviation, CAPA, and investigation · Documentation and records · Process validation · Laboratory and QC controls 2026-08-18 4 findings Suretec Innovations, LLCComplaint and recall handling · Deviation, CAPA, and investigation 2026-08-18 3 findings Veterinary Pharmacy CorporationDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Contamination control 2026-08-12 3 findings Sentiss Pharma Pvt. Ltd.Training and personnel · Quality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2026-08-05 9 findings SNJ Labs Private Ltd.Laboratory and QC controls · Equipment and facility · Computer system validation · Material and supplier control 2026-08-05 5 findings MSN Life Sciences Private Limited, Unit IIDeviation, CAPA, and investigation · Equipment and facility 2026-08-05 4 findings Zydus Lifesciences LimitedQuality unit oversight · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Process validation · Computer system validation 2026-08-05 7 findings Emcure Pharmaceuticals LimitedEquipment and facility · Computer system validation · Complaint and recall handling · Laboratory and QC controls · Material and supplier control · Aseptic processing and sterility assurance 2026-08-05 6 findings Baxalta US Inc.Equipment and facility · Process validation · Quality unit oversight · Laboratory and QC controls · Deviation, CAPA, and investigation 2026-08-04 5 findings Dabur India LimitedCleaning validation · Quality unit oversight · Laboratory and QC controls 2026-08-04 4 findings Woodbine Products Company Inc.Quality unit oversight · Material and supplier control · Process validation 2026-08-04 3 findings Cascade Specialty Pharmacy LLCQuality unit oversight · Equipment and facility · Stability and storage · Laboratory and QC controls 2026-07-31 4 findings Gascó Industrial CorporationContamination control · Equipment and facility · Laboratory and QC controls · Labeling and packaging · Process validation · Material and supplier control · Quality unit oversight · Stability and storage · Complaint and recall handling 2026-07-28 13 findings The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby LaboratoriesQuality unit oversight · Deviation, CAPA, and investigation · Other quality system 2026-07-28 3 findings Micro-X Ltd.Other quality system · Complaint and recall handling 2026-07-28 5 findings Veganic SKN LimitedContamination control · Laboratory and QC controls · Material and supplier control · Stability and storage · Quality unit oversight 2026-07-28 6 findings Reliance Life Sciences Private LimitedDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls 2026-07-28 3 findings Strides Pharma Science LimitedLaboratory and QC controls · Material and supplier control · Other quality system · Equipment and facility · Computer system validation 2026-07-28 5 findings Aptuit LtdMaterial and supplier control · Contamination control · Laboratory and QC controls · Quality unit oversight · Deviation, CAPA, and investigation 2026-07-28 6 findings Invitro Research Solutions Private LtdProcess validation · Laboratory and QC controls · Deviation, CAPA, and investigation 2026-07-28 4 findings Neeyaan LLCProcess validation · Quality unit oversight · Material and supplier control · Labeling and packaging · Documentation and records · Equipment and facility · Other quality system · Laboratory and QC controls · Stability and storage 2026-07-28 25 findings Smithfield Biosciencs, Inc.Material and supplier control · Process validation · Documentation and records · Stability and storage · Training and personnel · Other quality system 2026-07-27 6 findings Dabur India LimitedProcess validation · Equipment and facility · Quality unit oversight 2026-07-27 7 findings Wacker Biotech B.V.Equipment and facility · Laboratory and QC controls · Data integrity · Process validation 2026-07-27 5 findings Macau-Union Pharmaceutical LimitedMaterial and supplier control · Stability and storage · Laboratory and QC controls · Documentation and records · Process validation · Equipment and facility 2026-07-27 8 findings Alkem Laboratories LimitedQuality unit oversight · Complaint and recall handling · Material and supplier control · Equipment and facility · Process validation · Deviation, CAPA, and investigation 2026-07-27 7 findings Wizcure Pharmaa Private LimitedLaboratory and QC controls · Aseptic processing and sterility assurance · Process validation · Equipment and facility · Quality unit oversight 2026-07-27 7 findings University Of Pittsburgh Medical Center Centralized PackagingEquipment and facility · Deviation, CAPA, and investigation · Stability and storage 2026-07-27 3 findings Novel Laboratories, Inc. d.b.a Lupin SomersetDeviation, CAPA, and investigation · Material and supplier control · Quality unit oversight 2026-07-27 3 findings Sterigenics US , LLCComplaint and recall handling · Quality unit oversight · Deviation, CAPA, and investigation 2026-07-27 3 findings Clongen Laboratories, LLCLaboratory and QC controls · Other quality system · Equipment and facility · Validation and qualification 2026-07-24 6 findings B Positive National Blood Services - Wyoming, LLC.Other quality system · Material and supplier control 2026-07-24 3 findings Bausch and Lomb IncorporatedStability and storage · Aseptic processing and sterility assurance · Complaint and recall handling 2026-07-24 3 findings Lt Col Luke Weather Jr Veterans Affairs Medical CenterEquipment and facility · Aseptic processing and sterility assurance · Training and personnel · Material and supplier control · Other quality system 2026-07-23 9 findings CSL Behring GmbHEquipment and facility · Complaint and recall handling · Quality unit oversight · Deviation, CAPA, and investigation 2026-07-22 5 findings Sincerus Florida, LLCQuality unit oversight · Equipment and facility · Contamination control · Process validation · Aseptic processing and sterility assurance 2026-07-22 7 findings Symbiosis Pharmaceutical Services LimitedStability and storage · Laboratory and QC controls · Aseptic processing and sterility assurance · Quality unit oversight · Deviation, CAPA, and investigation · Equipment and facility 2026-07-21 6 findings A. Nelson & Co. Ltd.Deviation, CAPA, and investigation · Complaint and recall handling · Process validation · Quality unit oversight 2026-07-21 4 findings BioMylz Pvt. Ltd.Quality unit oversight · Laboratory and QC controls · Process validation 2026-07-21 3 findings Shimoga ChemicalsDeviation, CAPA, and investigation · Process validation · Data integrity 2026-07-21 3 findings Almon Healthcare Private LimitedQuality unit oversight · Cleaning validation · Laboratory and QC controls 2026-07-21 3 findings Catalent Indiana LLCAseptic processing and sterility assurance · Documentation and records · Equipment and facility · Deviation, CAPA, and investigation · Quality unit oversight · Material and supplier control · Process validation 2026-07-17 8 findings Accura-Pac, Inc.Equipment and facility · Process validation · Computer system validation · Stability and storage · Material and supplier control 2026-07-16 5 findings Berkshire Sterile ManufacturingMaterial and supplier control · Deviation, CAPA, and investigation · Cleaning validation 2026-07-15 3 findings Allure Labs, LLCMaterial and supplier control · Laboratory and QC controls · Computer system validation 2026-07-15 3 findings Alvotech HfLaboratory and QC controls · Complaint and recall handling · Quality unit oversight · Aseptic processing and sterility assurance 2026-07-15 4 findings Misemer Pharmaceutical, Inc.Regulatory reporting and change control · Other quality system 2026-07-14 4 findings Biomat USA IncMaterial and supplier control · Other quality system 2026-07-14 3 findings Tarmac Products, IncEquipment and facility · Quality unit oversight · Process validation · Material and supplier control 2026-07-14 4 findings Turbare ManufacturingDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Quality unit oversight · Training and personnel 2026-07-14 4 findings Spa De Soleil, Inc.Laboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight · Material and supplier control 2026-07-14 5 findings International Medication Systems LimitedEquipment and facility · Aseptic processing and sterility assurance 2026-07-14 3 findings Bentley Laboratories LLCQuality unit oversight · Deviation, CAPA, and investigation · Equipment and facility · Computer system validation · Laboratory and QC controls · Process validation 2026-07-13 8 findings MSN Laboratories Private LimitedEquipment and facility · Quality unit oversight · Laboratory and QC controls · Material and supplier control 2026-07-13 4 findings Cliantha Research LimitedOther quality system 2026-07-13 4 findings Biotechnologines farmacijos centras Biotechpharma UABEquipment and facility · Environmental monitoring · Other quality system 2026-07-13 4 findings Zhejiang Huahai Pharmaceutical Co., Ltd.Laboratory and QC controls · Computer system validation · Equipment and facility · Deviation, CAPA, and investigation · Quality unit oversight · Complaint and recall handling · Aseptic processing and sterility assurance 2026-07-13 9 findings Siegfried Pharma AGLaboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation 2026-07-13 5 findings RayzeBio, IncDocumentation and records · Material and supplier control · Equipment and facility · Quality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance · Training and personnel · Deviation, CAPA, and investigation 2026-07-13 11 findings Enemeez LLCProcess validation · Laboratory and QC controls · Material and supplier control · Quality unit oversight 2026-07-13 4 findings Dr. J Skinclinic, IncQuality unit oversight · Training and personnel · Laboratory and QC controls · Process validation · Material and supplier control · Stability and storage · Equipment and facility 2026-07-13 7 findings PETNET Solutions IncOther quality system · Process validation · Equipment and facility 2026-07-13 3 findings Nanjing Cuccess Pharmaceutical Co., LtdEquipment and facility · Stability and storage 2026-07-10 3 findings PharmaEssentia Corp.Aseptic processing and sterility assurance · Equipment and facility · Other quality system · Material and supplier control · Deviation, CAPA, and investigation · Computer system validation 2026-07-10 9 findings Custom Analytics LLCContamination control · Deviation, CAPA, and investigation · Equipment and facility 2026-07-10 3 findings Hospira, Inc.Quality unit oversight · Process validation · Equipment and facility · Other quality system 2026-07-10 6 findings Isorx Cyclotron CenterTraining and personnel · Other quality system · Documentation and records · Deviation, CAPA, and investigation · Material and supplier control 2026-07-10 7 findings Gilead Sciences, Inc.Other quality system · Aseptic processing and sterility assurance · Labeling and packaging · Quality unit oversight 2026-07-10 5 findings Eosera, Inc.Equipment and facility · Quality unit oversight · Other quality system · Laboratory and QC controls · Deviation, CAPA, and investigation · Process validation · Material and supplier control 2026-07-10 9 findings Apotek Production & Laboratorier ABComputer system validation · Documentation and records · Aseptic processing and sterility assurance · Process validation · Equipment and facility · Laboratory and QC controls 2026-07-10 9 findings Bora Pharmaceuticals Injectables IncContamination control · Laboratory and QC controls · Quality unit oversight · Deviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance 2026-07-10 6 findings Fujifilm Diosynth Biotechnologies USA Inc.Other quality system · Equipment and facility 2026-07-10 4 findings Aurorium LLCLaboratory and QC controls · Quality unit oversight · Other quality system 2026-07-10 4 findings Jiangsu Intco Medical Products Co., LtdStability and storage · Process validation · Material and supplier control 2026-07-09 4 findings Catalent Indiana LLCQuality unit oversight · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Process validation · Documentation and records · Material and supplier control 2026-07-08 8 findings VA San Diego Healthcare SystemsAseptic processing and sterility assurance · Equipment and facility · Other quality system · Contamination control · Material and supplier control · Training and personnel 2026-07-06 10 findings Richmond VA Medical CenterTraining and personnel · Aseptic processing and sterility assurance · Equipment and facility · Other quality system 2026-07-06 8 findings Mixlab WI LLCDocumentation and records · Quality unit oversight · Stability and storage · Equipment and facility · Material and supplier control · Laboratory and QC controls 2026-07-01 7 findings QuVa Pharma IncDeviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance 2026-07-01 3 findings Huons Co., Ltd.Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls 2026-06-23 4 findings Pharmaneek IncEquipment and facility · Other quality system · Contamination control 2026-06-22 3 findings Sante Manufacturing Inc.Quality unit oversight · Process validation · Material and supplier control 2026-06-16 3 findings Pharmathen International S.A.Aseptic processing and sterility assurance 2026-06-16 4 findings Fagron BVEquipment and facility · Aseptic processing and sterility assurance · Quality unit oversight · Deviation, CAPA, and investigation 2026-06-09 15 findings Macau-Union Pharmaceutical LimitedQuality unit oversight · Material and supplier control · Laboratory and QC controls · Stability and storage 2026-06-09 4 findings HealthPartners Neuroscience Center Research and InnovationLaboratory and QC controls · Equipment and facility 2026-06-02 3 findings Laboratorios Jaloma S.A. de C.V.Computer system validation · Laboratory and QC controls · Quality unit oversight 2026-06-02 4 findings Wells Pharma of Houston LLCLabeling and packaging · Stability and storage · Laboratory and QC controls · Aseptic processing and sterility assurance · Quality unit oversight 2026-05-27 6 findings BPI Labs, LLCEquipment and facility · Laboratory and QC controls · Quality unit oversight · Regulatory reporting and change control 2026-05-27 4 findings Central Alabama Veterans Health Care SystemEquipment and facility · Other quality system · Aseptic processing and sterility assurance · Environmental monitoring 2026-05-27 8 findings Dabur India LimitedEquipment and facility · Quality unit oversight · Process validation 2026-05-26 7 findings Intas Pharmaceutical LimitedDocumentation and records · Quality unit oversight · Deviation, CAPA, and investigation 2026-05-26 3 findings Adnan Dahdul, MDOther quality system · Deviation, CAPA, and investigation 2026-05-26 3 findings JW Nutritional LLCMaterial and supplier control · Laboratory and QC controls · Process validation 2026-05-19 3 findings Harbin Jixianglong Biotech Co., Ltd.Process validation · Laboratory and QC controls · Quality unit oversight · Aseptic processing and sterility assurance 2026-05-19 4 findings Hangzhou Yiqi Biotechnology Co., LtdAseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls 2026-05-19 4 findings Excel VisionAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Other quality system · Computer system validation · Equipment and facility · Process validation 2026-05-15 10 findings IDO Pharm Co., Ltd.Quality unit oversight · Process validation · Laboratory and QC controls 2026-05-12 3 findings ProRx LLCAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Environmental monitoring · Equipment and facility · Documentation and records · Quality unit oversight · Contamination control 2026-05-12 15 findings SCA Pharmaceuticals LLCDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility 2026-05-08 3 findings Staska Pharmaceuticals, IncLaboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2026-05-08 3 findings Somerset Therapeutics Private LimitedAseptic processing and sterility assurance · Laboratory and QC controls · Documentation and records · Complaint and recall handling 2026-05-06 9 findings Shouguang Fukang Pharmaceutical Co., Ltd.Material and supplier control · Other quality system · Quality unit oversight · Equipment and facility · Aseptic processing and sterility assurance · Process validation 2026-05-06 8 findings Bio-Thera Solutions, Ltd.Aseptic processing and sterility assurance · Process validation · Laboratory and QC controls · Quality unit oversight · Computer system validation 2026-05-06 5 findings Ajinomoto Company Inc.Laboratory and QC controls · Stability and storage · Deviation, CAPA, and investigation 2026-05-06 3 findings CareFusion 213, LLCEquipment and facility · Laboratory and QC controls · Aseptic processing and sterility assurance 2026-05-05 3 findings Respilon Production S.R.O.Material and supplier control · Documentation and records · Stability and storage · Laboratory and QC controls · Process validation 2026-05-05 5 findings Active Cosmetics Manufacturing Inc.Deviation, CAPA, and investigation · Material and supplier control · Laboratory and QC controls 2026-05-05 3 findings Allergan Pharmaceuticals Ireland UnlimitedValidation and qualification · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls 2026-05-01 5 findings Fujifilm Diosynth Biotechnologies Texas, LLCStability and storage · Other quality system · Contamination control · Computer system validation · Laboratory and QC controls 2026-04-29 7 findings Eugia Pharma Specialities LimitedLaboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2026-04-29 4 findings Excel VisionAseptic processing and sterility assurance · Laboratory and QC controls 2026-04-28 3 findings Lexia LLCProcess validation · Stability and storage · Laboratory and QC controls · Material and supplier control · Quality unit oversight 2026-04-28 5 findings Foshan Miwei Cosmetics Co., Ltd.Quality unit oversight · Material and supplier control · Stability and storage 2026-04-28 3 findings Lonza AGMaterial and supplier control · Process validation · Laboratory and QC controls · Other quality system 2026-04-24 4 findings Global Calcium Private LimitedLaboratory and QC controls · Cleaning validation · Quality unit oversight 2026-04-23 5 findings BayCare Integrated Service Center LLCAseptic processing and sterility assurance · Process validation · Deviation, CAPA, and investigation · Quality unit oversight 2026-04-22 7 findings Revive Rx LLCAseptic processing and sterility assurance · Contamination control · Training and personnel 2026-04-22 5 findings Apollo Care, LLCAseptic processing and sterility assurance · Equipment and facility · Environmental monitoring · Contamination control 2026-04-21 13 findings RC Outsourcing, LLCAseptic processing and sterility assurance · Laboratory and QC controls · Material and supplier control · Documentation and records · Deviation, CAPA, and investigation 2026-04-21 12 findings Thrive Health and Wellness, LLC dba Thrive Health SolutionsAseptic processing and sterility assurance 2026-04-21 5 findings Pro Numb Tattoo Numbing Spray, LLCQuality unit oversight · Stability and storage · Process validation · Laboratory and QC controls · Material and supplier control 2026-04-21 5 findings Par Health USA, LLC & Endo USA, Inc.Aseptic processing and sterility assurance 2026-04-21 3 findings Chemco CorporationMaterial and supplier control · Deviation, CAPA, and investigation · Equipment and facility 2026-04-14 3 findings Patheon Italia S.p.A.Aseptic processing and sterility assurance · Quality unit oversight · Contamination control · Process validation 2026-04-09 5 findings Orchid Pharma LimitedEquipment and facility · Computer system validation · Quality unit oversight · Cleaning validation · Other quality system · Material and supplier control 2026-04-09 7 findings Hikal LimitedOther quality system · Computer system validation · Equipment and facility 2026-04-03 5 findings Micro Labs LimitedQuality unit oversight · Deviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility 2026-03-25 4 findings Yangzhou H&R Plastic Daily Chemical Co., Ltd.Quality unit oversight · Laboratory and QC controls · Process validation · Material and supplier control 2026-03-24 4 findings Avella of Deer Valley, Inc. dba AvellaAseptic processing and sterility assurance · Labeling and packaging 2026-03-23 3 findings Avella of Deer Valley, IncDocumentation and records · Aseptic processing and sterility assurance · Equipment and facility · Contamination control · Deviation, CAPA, and investigation 2026-03-23 7 findings Avella of Deer Valley dba Avella Specialty PharmacyAseptic processing and sterility assurance · Quality unit oversight · Labeling and packaging 2026-03-23 3 findings Avella of Deer Valley, Inc. Store 38Quality unit oversight · Stability and storage · Labeling and packaging 2026-03-23 3 findings Avella of Deer Valley dba Avella Specialty PharmacyOther quality system · Quality unit oversight · Aseptic processing and sterility assurance 2026-03-23 3 findings Apothecary Pharma, LLCTraining and personnel · Equipment and facility · Aseptic processing and sterility assurance · Material and supplier control · Quality unit oversight · Contamination control · Documentation and records · Environmental monitoring 2026-03-17 26 findings Patcos Cosmetics Pvt. Ltd.Process validation · Quality unit oversight · Material and supplier control 2026-03-17 3 findings Vedic Lifesciences Pvt. Ltd.Equipment and facility 2026-03-17 4 findings Flowchem Pharma Private LimitedCleaning validation · Material and supplier control · Laboratory and QC controls · Equipment and facility 2026-03-17 4 findings Gland Chemicals Private LimitedAseptic processing and sterility assurance · Contamination control · Computer system validation · Process validation · Documentation and records · Laboratory and QC controls 2026-03-13 10 findings Tentamus India Private LimitedLaboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight 2026-03-10 3 findings Maiva Pharma Private LimitedAseptic processing and sterility assurance · Quality unit oversight · Deviation, CAPA, and investigation · Other quality system · Equipment and facility · Laboratory and QC controls 2026-03-06 8 findings Fukuzyu Pharmaceutical Co., Ltd.Validation and qualification · Equipment and facility · Data integrity · Deviation, CAPA, and investigation 2026-03-03 4 findings Fujian Genohope Biotech LtdEquipment and facility · Process validation · Material and supplier control 2026-03-03 5 findings GenoGenix LLCLaboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Quality unit oversight · Material and supplier control · Other quality system · Environmental monitoring · Labeling and packaging · Process validation · Contamination control · Documentation and records · Deviation, CAPA, and investigation · Training and personnel 2026-03-03 31 findings AQ USA Inc., d.b.a Ross Healthcare Inc.Stability and storage · Material and supplier control · Quality unit oversight · Laboratory and QC controls 2026-02-24 5 findings Aurobindo Pharma Limited, Unit VIIEquipment and facility · Laboratory and QC controls · Computer system validation · Complaint and recall handling · Quality unit oversight · Deviation, CAPA, and investigation · Documentation and records 2026-02-20 8 findings Lupin LimitedComplaint and recall handling · Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Laboratory and QC controls 2026-02-18 6 findings Cosmetic Manufacturers Pty Ltd.Equipment and facility · Laboratory and QC controls · Process validation 2026-02-17 4 findings Eugia Pharma Specialities LimitedDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight · Training and personnel 2026-02-12 11 findings F.H. Investments Inc dba Asteria HealthProcess validation · Laboratory and QC controls · Aseptic processing and sterility assurance · Documentation and records · Quality unit oversight · Computer system validation · Stability and storage 2026-02-10 10 findings Boothwyn Pharmacy, LLCAseptic processing and sterility assurance · Equipment and facility · Environmental monitoring 2026-02-10 5 findings Signature Formulations, LLCLaboratory and QC controls · Cleaning validation · Quality unit oversight · Equipment and facility 2026-02-10 4 findings Ipca Laboratories LimitedCleaning validation · Equipment and facility · Laboratory and QC controls 2026-02-05 3 findings US Specialty Formulations LLCMaterial and supplier control · Aseptic processing and sterility assurance · Quality unit oversight · Stability and storage · Laboratory and QC controls 2026-02-03 6 findings HTO Nevada, Inc. dba KirkmanStability and storage · Documentation and records · Quality unit oversight 2026-02-03 3 findings Baxter Oncology GmbHAseptic processing and sterility assurance · Equipment and facility · Material and supplier control · Process validation · Deviation, CAPA, and investigation · Documentation and records · Quality unit oversight 2026-02-02 11 findings Empower Clinic Services LLC dba Empower PharmaDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls · Process validation · Quality unit oversight · Material and supplier control · Equipment and facility 2026-01-27 9 findings Fulijaya Manufacturing SDN. BHD.Laboratory and QC controls · Stability and storage 2026-01-27 3 findings Denver Solutions, LLCProcess validation · Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility 2026-01-26 6 findings Nubratori, Inc.Process validation · Equipment and facility · Aseptic processing and sterility assurance 2026-01-22 3 findings Pine Pharmaceuticals LLCProcess validation · Training and personnel · Deviation, CAPA, and investigation · Other quality system · Aseptic processing and sterility assurance 2026-01-22 5 findings Petscript IncQuality unit oversight · Equipment and facility · Training and personnel · Laboratory and QC controls · Aseptic processing and sterility assurance · Material and supplier control · Documentation and records · Stability and storage · Deviation, CAPA, and investigation 2026-01-22 16 findings Sato Pharmaceutical Co., Ltd.Equipment and facility · Quality unit oversight · Laboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Contamination control · Stability and storage 2026-01-21 10 findings Lupin LimitedLaboratory and QC controls · Aseptic processing and sterility assurance · Computer system validation · Other quality system 2026-01-21 6 findings Fresenius Kabi Compounding LLCAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Quality unit oversight · Material and supplier control 2026-01-20 7 findings Integrity Partners GroupMaterial and supplier control · Process validation · Laboratory and QC controls · Equipment and facility 2026-01-20 4 findings Inotiv Inc.Validation and qualification 2026-01-16 3 findings OSRX IncDeviation, CAPA, and investigation · Computer system validation · Aseptic processing and sterility assurance · Laboratory and QC controls 2026-01-16 4 findings Qualgen LLCAseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight · Contamination control 2026-01-16 5 findings Shilpa Medicare LimitedAseptic processing and sterility assurance · Contamination control · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls 2026-01-15 8 findings Biocon Biologics LimitedLaboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation · Quality unit oversight 2026-01-15 5 findings Alembic Pharmaceuticals LimitedAseptic processing and sterility assurance · Equipment and facility · Quality unit oversight 2026-01-07 5 findings Alembic Pharmaceuticals LimitedLaboratory and QC controls · Deviation, CAPA, and investigation · Validation and qualification · Other quality system · Quality unit oversight · Aseptic processing and sterility assurance · Equipment and facility · Process validation · Computer system validation 2026-01-07 10 findings LiquidCapsule Manufacturing, LLCDocumentation and records · Material and supplier control · Laboratory and QC controls · Process validation · Stability and storage 2026-01-06 5 findings Absolutely NaturalMaterial and supplier control · Deviation, CAPA, and investigation · Laboratory and QC controls 2026-01-06 3 findings Dr. Reddy’s Laboratories LimitedProcess validation · Deviation, CAPA, and investigation · Material and supplier control · Laboratory and QC controls · Equipment and facility 2026-01-05 5 findings