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.
117
Published 483s in 2025
12
Months with records
Browse 2025 by month
Most recent Form 483s in 2025
Showing 25 of 117 — open a month above for the full list.
| Company | FEI | Establishment type | Location | Issued | Source |
|---|---|---|---|---|---|
| Intas Pharmaceutical Limited | 3005890633 | Drug Product Manufacturer | India | Sep 17, 2025 | FDA |
| Ajinomoto Company Inc. | 3002806336 | API (animal origin) Manufacturer | Japan | Feb 21, 2025 | FDA |
| Bio-Thera Solutions, Ltd. | 3017231337 | Drug Substance Manufacturer | China | Jan 17, 2025 | FDA |
| Somerset Therapeutics Private Limited | 3003821988 | Sterile Drug Manufacturer | India | Feb 21, 2025 | FDA |
| Shouguang Fukang Pharmaceutical Co., Ltd. | 3003941038 | API (animal origin) Manufacturer | China | Feb 21, 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 |
| Nubratori, Inc. | 3010166491 | Outsourcing Facility | California, United States | Dec 11, 2025 | FDA |
| Pine Pharmaceuticals LLC | 3010943533 | Outsourcing Facility | New York, United States | Nov 14, 2025 | FDA |