Published FDA Form 483 Inspection Reports (259 Indexed)
Every Form 483 translated into plain English with observations mapped clause-by-clause to 21 CFR Part 111, 117, 211, 820, and MoCRA.
FDA Form 483 issued to Victory Medical Center Pharmacy (FEI 3010485868) on 2026-09-10 following an inspection of its producer of sterile and non sterile drug products operations in Texas. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Greenwich Rx (FEI 3043120213) on 2026-09-09 following an inspection of its producer of sterile and non sterile drug products operations in Texas. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Right Value Drug Stores LLC (FEI 3010589333) on 2026-09-08 following an inspection of its outsourcing facility operations in Texas. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Personnel GMP Training, Gowning & Hygienic Practices.
FDA Form 483 issued to RC Outsourcing LLC (FEI 3011967886) on 2026-09-03 following an inspection of its outsourcing facility operations in Ohio. The report documents 5 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Cleaning Validation, Sanitation Logs & Pest Control.
FDA Form 483 issued to OPS International Inc dba Olympia Pharmaceuticals (FEI 3009724085) on 2026-09-03 following an inspection of its outsourcing facility operations in Florida. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Cleaning Validation, Sanitation Logs & Pest Control.
FDA Form 483 issued to TAILSTORM HEALTH INC (FEI 3015929581) on 2026-08-28 following an inspection of its outsourcing facility operations in Arizona. The report documents 3 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
FDA Form 483 issued to Houston Rx LLC (FEI 3045022201) on 2026-08-28 following an inspection of its producer of sterile drug products operations in Texas. The report documents 4 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to STAQ Pharma of Ohio LLC (FEI 3025336457) on 2026-08-19 following an inspection of its outsourcing facility operations in Ohio. The report documents 5 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
FDA Form 483 issued to Imprimis NJOF LLC (FEI 3013024146) on 2026-08-18 following an inspection of its outsourcing facility operations in New Jersey. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
FDA Form 483 issued to Carolina Infusion LLC (FEI 3015826782) on 2026-08-18 following an inspection of its producer of sterile and non sterile drug products operations in South Carolina. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
FDA Form 483 issued to IntegraDose Compounding Services LLC (FEI 3014483112) on 2026-08-12 following an inspection of its outsourcing facility operations in Minnesota. The report documents 4 inspection observations centered on Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems, Finished Product Testing, Stability & Expiration Dating.
FDA Form 483 issued to OurPharma LLC (FEI 3014064135) on 2026-08-12 following an inspection of its outsourcing facility operations in Arkansas. The report documents 5 inspection observations centered on Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
FDA Form 483 issued to CD Pharmacy LLC dba Red Rock Pharmacy (FEI 3032406608) on 2026-07-31 following an inspection of its producer of sterile and non sterile drug products operations in Utah. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Apollo Care LLC (FEI 3013927023) on 2026-07-28 following an inspection of its outsourcing facility operations in Montana. The report documents 3 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Cascade Specialty Pharmacy LLC (FEI 3015133983) on 2026-07-17 following an inspection of its producer of non sterile drug products operations in Washington. The report documents 4 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Personnel GMP Training, Gowning & Hygienic Practices.
FDA Form 483 issued to Brookfield Medical Surgical Supplies Inc (FEI 3011430551) on 2026-07-10 following an inspection of its outsourcing facility operations in Connecticut. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
FDA Form 483 issued to Annovex Pharma Inc (FEI 3020928491) on 2026-07-03 following an inspection of its outsourcing facility operations in Virginia. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
FDA Form 483 issued to XeCare LLC (FEI 3017865039) on 2026-06-17 following an inspection of its producer of sterile and non sterile drug products operations in Ohio. The report documents 3 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Jubilant HollisterStier LLC (FEI 3010477) on 2026-06-17 following an inspection of its drug manufacturer operations in Washington. The report documents 4 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Personnel GMP Training, Gowning & Hygienic Practices.
FDA Form 483 issued to Fayetteville VA Medical Center (FEI 1073803) on 2026-06-15 following an inspection of its producer of sterile drug products operations in North Carolina. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
FDA Form 483 issued to Lt Col Luke Weather Jr Veterans Affairs Medical Center (FEI 1074265) on 2026-06-04 following an inspection of its producer of sterile drug products operations in Tennessee. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
FDA Form 483 issued to PQ Pharmacy LLC (FEI 3017374013) on 2026-06-01 following an inspection of its outsourcing facility operations in Florida. The report documents 3 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Master Manufacturing & Batch Production Records (MMR/BPR).
FDA Form 483 issued to Sincerus Florida, LLC (FEI 3012384835) on 2026-05-29 following an inspection of its outsourcing facility operations in Florida. The report documents 4 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Finished Product Testing, Stability & Expiration Dating.
FDA Form 483 issued to Shilpa Medicare Limited (FEI 3018694237) on 2026-05-29 following an inspection of its drug manufacturer operations in India. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Master Manufacturing & Batch Production Records (MMR/BPR).
FDA Form 483 issued to Strides Pharma Science Limited (FEI 3004554612) on 2026-05-20 following an inspection of its human drug manufacturer operations in India. The report documents 2 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Lonza Bend Inc. (FEI 3003722743) on 2026-05-19 following an inspection of its manufacturer operations in Oregon. The report documents 3 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Emcure Pharmaceuticals Limited (FEI 301459503) on 2026-05-15 following an inspection of its manufacturer operations in India. The report documents 4 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR).
FDA Form 483 issued to Mylan Laboratories Limited (FEI 3005587313) on 2026-05-15 following an inspection of its finished drug product manufacturer operations in India. The report documents 5 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Fresenius Kabi USA, LLC (FEI 3001833549) on 2026-05-14 following an inspection of its sterile drug manufacturer operations in New York. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Cleaning Validation, Sanitation Logs & Pest Control.
FDA Form 483 issued to Richmond VA Medical Center (FEI 1174302) on 2026-05-12 following an inspection of its producer of sterile drug products operations in Virginia. The report documents 3 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Finished Product Testing, Stability & Expiration Dating.
FDA Form 483 issued to VA San Diego Healthcare Systems (FEI 2071629) on 2026-05-08 following an inspection of its producer of sterile drug products operations in California. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Cleaning Validation, Sanitation Logs & Pest Control.
FDA Form 483 issued to Alvotech Hf (FEI 3013702557) on 2026-05-08 following an inspection of its biological drug substance/product manufacturer operations in Iceland. The report documents 5 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Finished Product Testing, Stability & Expiration Dating.
FDA Form 483 issued to Philips Oral Healthcare, LLC (FEI 1000126901) on 2026-05-08 following an inspection of its specification developer operations in Washington. The report documents 2 inspection observations centered on Finished Product Testing, Stability & Expiration Dating.
FDA Form 483 issued to Perrigo New York, Inc. (FEI 2450054) on 2026-05-08 following an inspection of its drug manufacturer operations in New York. The report documents 3 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Turbare Manufacturing (FEI 3027507354) on 2026-05-07 following an inspection of its outsourcing facility operations in Arkansas. The report documents 4 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Zydus Lifesciences Limited (FEI 3012977526) on 2026-05-05 following an inspection of its sterile manufacturer operations in India. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Master Manufacturing & Batch Production Records (MMR/BPR).
FDA Form 483 issued to QuVa Pharma Inc (FEI 3012053582) on 2026-05-04 following an inspection of its outsourcing facility operations in Texas. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Cleaning Validation, Sanitation Logs & Pest Control.
FDA Form 483 issued to Alkem Laboratories Limited (FEI 3006370524) on 2026-05-01 following an inspection of its finished drug product manufacturer operations in India. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, CAPA, Out-of-Specification (OOS) & Complaint Investigations.
FDA Form 483 issued to Catalent Indiana LLC (FEI 3005949964) on 2026-04-24 following an inspection of its sterile drug manufacturer operations in Indiana. The report documents 4 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), CAPA, Out-of-Specification (OOS) & Complaint Investigations.
FDA Form 483 issued to Catalent Indiana LLC (FEI 3005949964) on 2026-04-24 following an inspection of its sterile drug manufacturer operations in Indiana. The report documents 5 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Master Manufacturing & Batch Production Records (MMR/BPR).
FDA Form 483 issued to Zhejiang Huahai Pharmaceutical Co., Ltd. (FEI 3003999190) on 2026-04-24 following an inspection of its drug manufacturer operations in China. The report documents 2 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations, Master Manufacturing & Batch Production Records (MMR/BPR).
FDA Form 483 issued to Jiangsu Hansoh Pharmaceutical Group Co Ltd. (FEI 3008316144) on 2026-04-24 following an inspection of its sterile drug manufacturer operations in China. The report documents 3 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations, Personnel GMP Training, Gowning & Hygienic Practices.
FDA Form 483 issued to BioLife Plasma Services, L.P. (FEI 3025527098) on 2026-04-22 following an inspection of its plasmapheresis center operations in Nevada. The report documents 4 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Finished Product Testing, Stability & Expiration Dating.
FDA Form 483 issued to BPI Labs, LLC (FEI 3015156709) on 2026-04-17 following an inspection of its outsourcing facility operations in Florida. The report documents 5 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Cliantha Research Limited (FEI 3017682080) on 2026-04-17 following an inspection of its producer of regulated products operations in India. The report documents 2 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Cleaning Validation, Sanitation Logs & Pest Control.
FDA Form 483 issued to Novel Laboratories, Inc. d.b.a Lupin Somerset (FEI 3006271438) on 2026-04-17 following an inspection of its drug manufacturer operations in New Jersey. The report documents 3 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
FDA Form 483 issued to Central Alabama Veterans Health Care System (FEI 1073935) on 2026-04-16 following an inspection of its producer of sterile drug products operations in Alabama. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Lonza Biologics, Inc. (FEI 3001451441) on 2026-04-16 following an inspection of its drug manufacturer operations in New Hampshire. The report documents 5 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
FDA Form 483 issued to Biomat USA Inc (FEI 3014028128) on 2026-04-14 following an inspection of its source plasma establishment operations in Texas. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
FDA Form 483 issued to Wells Pharma of Houston LLC (FEI 3016710931) on 2026-04-13 following an inspection of its outsourcing facility operations in Texas. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Wells Pharmacy Inc (FEI 3011761321) on 2026-04-09 following an inspection of its outsourcing facility operations in Tennessee. The report documents 4 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Cleaning Validation, Sanitation Logs & Pest Control.
FDA Form 483 issued to Pharmaneek Inc (FEI 3014484244) on 2026-04-08 following an inspection of its producer of non sterile drug products operations in Indiana. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Master Manufacturing & Batch Production Records (MMR/BPR).
FDA Form 483 issued to Fujifilm Diosynth Biotechnologies USA Inc. (FEI 3000718852) on 2026-03-27 following an inspection of its drug substance manufacturer operations in North Carolina. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
FDA Form 483 issued to Allure Labs, LLC (FEI 3000204079) on 2026-03-27 following an inspection of its manufacturer operations in California. The report documents 3 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Label Control, Undeclared Allergens & Structure/Function Claims.
FDA Form 483 issued to Bentley Laboratories LLC (FEI 2244819) on 2026-03-27 following an inspection of its otc manufacturer operations in New Jersey. The report documents 4 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR).
FDA Form 483 issued to Charles River Laboratories, Inc. DBA Charles River, Endosafe (FEI 1053022) on 2026-03-27 following an inspection of its contract testing laboratory operations in South Carolina. The report documents 5 inspection observations centered on Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems, Finished Product Testing, Stability & Expiration Dating.
FDA Form 483 issued to Q-Med AB (FEI 3003347293) on 2026-03-27 following an inspection of its drug substance and drug product manufacturer operations in Sweden. The report documents 2 inspection observations centered on Label Control, Undeclared Allergens & Structure/Function Claims, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
FDA Form 483 issued to Revive Rx LLC (FEI 3016710945) on 2026-03-27 following an inspection of its producer of sterile and non sterile drug products operations in Texas. The report documents 3 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Becton Dickinson Infusion Therapy Systems, Inc. (FEI 1710034) on 2026-03-26 following an inspection of its drug manufacturer operations in Utah. The report documents 4 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Incoming Ingredient Identity Testing & COA Qualification.
FDA Form 483 issued to Cosmetics & Cleaners International LLC (FEI 3009878984) on 2026-03-26 following an inspection of its producer of regulated products operations in North Carolina. The report documents 5 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations.