FDA 483 Database
FDA Form 483s Issued in 2025
Every published Form FDA 483 issued in 2025, drawn from the FDA OII FOIA Electronic Reading Room. Drill into any month, or open a record to see the firm, FEI number, establishment type, and location.
118
Published 483s in 2025
12
Months with records
Browse 2025 by month
Most recent Form 483s in 2025
Showing 25 of 118 — open a month above for the full list.
Mixlab WI LLCFDA
- FEI
- 3005946041
- Issued
- Jul 24, 2025
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Wisconsin, United States
Intas Pharmaceutical LimitedFDA
- FEI
- 3005890633
- Issued
- Sep 17, 2025
- Establishment
- Drug Product Manufacturer
- Location
- India
Shouguang Fukang Pharmaceutical Co., Ltd.FDA
- FEI
- 3003941038
- Issued
- Feb 21, 2025
- Establishment
- API (animal origin) Manufacturer
- Location
- China
Ajinomoto Company Inc.FDA
- FEI
- 3002806336
- Issued
- Feb 21, 2025
- Establishment
- API (animal origin) Manufacturer
- Location
- Japan
Somerset Therapeutics Private LimitedFDA
- FEI
- 3003821988
- Issued
- Feb 21, 2025
- Establishment
- Sterile Drug Manufacturer
- Location
- India
Bio-Thera Solutions, Ltd.FDA
- FEI
- 3017231337
- Issued
- Jan 17, 2025
- Establishment
- Drug Substance Manufacturer
- Location
- China
Allergan Pharmaceuticals Ireland UnlimitedFDA
- FEI
- 3002806285
- Issued
- Jan 30, 2025
- Establishment
- Drug Product Manufacturer
- Location
- Ireland
Fujifilm Diosynth Biotechnologies Texas, LLCFDA
- FEI
- 3011948449
- Issued
- Mar 11, 2025
- Establishment
- Drug Substance Manufacturer
- Location
- United States
Lonza AGFDA
- FEI
- 3002930340
- Issued
- Oct 28, 2025
- Establishment
- Drug Substance Manufacturer
- Location
- Switzerland
Patheon Italia S.p.A.FDA
- FEI
- 3004110157
- Issued
- Feb 18, 2025
- Establishment
- Drug Manufacturer
- Location
- Italy
Orchid Pharma LimitedFDA
- FEI
- 3003747558
- Issued
- Feb 18, 2025
- Establishment
- API (animal origin) Manufacturer
- Location
- India
SMS Pharmaceutical Limited - Unit VIIFDA
- FEI
- 3008654585
- Issued
- Dec 12, 2025
- Establishment
- API (animal origin) Manufacturer
- Location
- India
Hikal LimitedFDA
- FEI
- 3003560263
- Issued
- Feb 7, 2025
- Establishment
- API and Intermediate Manufacturer
- Location
- India
Micro Labs LimitedFDA
- FEI
- 3004495158
- Issued
- Feb 7, 2025
- Establishment
- Finished Drug Product Manufacturer
- Location
- India
Alps Pharmaceutical Industrial Co., Ltd.FDA
- FEI
- 3002806352
- Issued
- Oct 17, 2025
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Japan
Hubei JXBio Pharmaceutical Co., Ltd.FDA
- FEI
- 3016784508
- Issued
- Mar 14, 2025
- Establishment
- API (animal origin) Manufacturer
- Location
- China
Lupin LimitedFDA
- FEI
- 3004819820
- Issued
- Nov 21, 2025
- Establishment
- Drug Manufacturer
- Location
- India
Zydus Lifesciences LimitedFDA
- FEI
- 3013712903
- Issued
- Sep 5, 2025
- Establishment
- Sterile Drug Manufacturer
- Location
- India
F.H. Investments Inc dba Asteria HealthFDA
- FEI
- 3038253438
- Issued
- Dec 19, 2025
- Establishment
- Outsourcing Facility
- Location
- Alabama, United States
Ipca Laboratories LimitedFDA
- FEI
- 3006057101
- Issued
- Dec 5, 2025
- Establishment
- API (animal origin) Manufacturer
- Location
- India
Baxter Oncology GmbHFDA
- FEI
- 3002806419
- Issued
- Sep 26, 2025
- Establishment
- Drug Manufacturer
- Location
- Germany
Empower Clinic Services LLC dba Empower PharmaFDA
- FEI
- 3011887629
- Issued
- Dec 14, 2025
- Establishment
- Outsourcing Facility
- Location
- Texas, United States
Denver Solutions, LLCFDA
- FEI
- 3013438582
- Issued
- Dec 11, 2025
- Establishment
- Outsourcing Facility
- Location
- Colorado, United States
Petscript IncFDA
- FEI
- 3010282564
- Issued
- Sep 18, 2025
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Texas, United States
Pine Pharmaceuticals LLCFDA
- FEI
- 3010943533
- Issued
- Nov 14, 2025
- Establishment
- Outsourcing Facility
- Location
- New York, United States
| Company | FEI | Establishment type | Location | Issued | Source |
|---|---|---|---|---|---|
| Mixlab WI LLC | 3005946041 | Producer of Non Sterile Drug Products | Wisconsin, United States | Jul 24, 2025 | FDA |
| Intas Pharmaceutical Limited | 3005890633 | Drug Product Manufacturer | India | Sep 17, 2025 | FDA |
| Shouguang Fukang Pharmaceutical Co., Ltd. | 3003941038 | API (animal origin) Manufacturer | China | Feb 21, 2025 | FDA |
| Ajinomoto Company Inc. | 3002806336 | API (animal origin) Manufacturer | Japan | Feb 21, 2025 | FDA |
| Somerset Therapeutics Private Limited | 3003821988 | Sterile Drug Manufacturer | India | Feb 21, 2025 | FDA |
| Bio-Thera Solutions, Ltd. | 3017231337 | Drug Substance Manufacturer | China | Jan 17, 2025 | FDA |
| Allergan Pharmaceuticals Ireland Unlimited | 3002806285 | Drug Product Manufacturer | Ireland | Jan 30, 2025 | FDA |
| Fujifilm Diosynth Biotechnologies Texas, LLC | 3011948449 | Drug Substance Manufacturer | United States | Mar 11, 2025 | FDA |
| Lonza AG | 3002930340 | Drug Substance Manufacturer | Switzerland | Oct 28, 2025 | FDA |
| Patheon Italia S.p.A. | 3004110157 | Drug Manufacturer | Italy | Feb 18, 2025 | FDA |
| Orchid Pharma Limited | 3003747558 | API (animal origin) Manufacturer | India | Feb 18, 2025 | FDA |
| SMS Pharmaceutical Limited - Unit VII | 3008654585 | API (animal origin) Manufacturer | India | Dec 12, 2025 | FDA |
| Hikal Limited | 3003560263 | API and Intermediate Manufacturer | India | Feb 7, 2025 | FDA |
| Micro Labs Limited | 3004495158 | Finished Drug Product Manufacturer | India | Feb 7, 2025 | FDA |
| Alps Pharmaceutical Industrial Co., Ltd. | 3002806352 | Active Pharmaceutical Ingredient Manufacturer | Japan | Oct 17, 2025 | FDA |
| Hubei JXBio Pharmaceutical Co., Ltd. | 3016784508 | API (animal origin) Manufacturer | China | Mar 14, 2025 | FDA |
| Lupin Limited | 3004819820 | Drug Manufacturer | India | Nov 21, 2025 | FDA |
| Zydus Lifesciences Limited | 3013712903 | Sterile Drug Manufacturer | India | Sep 5, 2025 | FDA |
| F.H. Investments Inc dba Asteria Health | 3038253438 | Outsourcing Facility | Alabama, United States | Dec 19, 2025 | FDA |
| Ipca Laboratories Limited | 3006057101 | API (animal origin) Manufacturer | India | Dec 5, 2025 | FDA |
| Baxter Oncology GmbH | 3002806419 | Drug Manufacturer | Germany | Sep 26, 2025 | FDA |
| Empower Clinic Services LLC dba Empower Pharma | 3011887629 | Outsourcing Facility | Texas, United States | Dec 14, 2025 | FDA |
| Denver Solutions, LLC | 3013438582 | Outsourcing Facility | Colorado, United States | Dec 11, 2025 | FDA |
| Petscript Inc | 3010282564 | Producer of Sterile and Non Sterile Drug Products | Texas, United States | Sep 18, 2025 | FDA |
| Pine Pharmaceuticals LLC | 3010943533 | Outsourcing Facility | New York, United States | Nov 14, 2025 | FDA |