FDA 483 Database
FDA Form 483s Issued in September 2025
Every published Form FDA 483 issued in September 2025, drawn from the FDA OII FOIA Electronic Reading Room. Each row links to the FDA source record.
19
Published 483s in September 2025
OII FOIA
Source
Form 483s issued in September 2025
| Company | FEI | Establishment type | Location | Issued | Source |
|---|---|---|---|---|---|
| Intas Pharmaceutical Limited | 3005890633 | Drug Product Manufacturer | India | Sep 17, 2025 | FDA |
| Zydus Lifesciences Limited | 3013712903 | Sterile Drug Manufacturer | India | Sep 5, 2025 | FDA |
| Baxter Oncology GmbH | 3002806419 | Drug Manufacturer | Germany | Sep 26, 2025 | FDA |
| Petscript Inc | 3010282564 | Producer of Sterile and Non Sterile Drug Products | Texas, United States | Sep 18, 2025 | FDA |
| Lupin Limited | 3015392060 | Sterile Drug Manufacturer | India | Sep 16, 2025 | FDA |
| Qualgen LLC | 3011286349 | Outsourcing Facility | Oklahoma, United States | Sep 4, 2025 | FDA |
| Biocon Biologics Limited | 3015283245 | Drug Manufacturer | India | Sep 3, 2025 | FDA |
| Sun Pharmaceuticals Medicare Ltd. | 3002957541 | Finished Pharmaceutical Manufacturer | India | Sep 19, 2025 | FDA |
| ProRx LLC | 3022250654 | Outsourcing Facility | Pennsylvania, United States | Sep 19, 2025 | FDA |
| Park Avenue Compounding | 1972829 | Outsourcing Facility | Missouri, United States | Sep 23, 2025 | FDA |
| Central Admixture Pharmacy Services Inc | 3009590582 | Outsourcing Facility | Pennsylvania, United States | Sep 5, 2025 | FDA |
| Farmakeio Outsourcing LLC | 3014982757 | Outsourcing Facility | Texas, United States | Sep 5, 2025 | FDA |
| Central Admixture Pharmacy Services Inc | 3014307835 | Outsourcing Facility | Arizona, United States | Sep 5, 2025 | FDA |
| North American Custom Laboratories LLC | 3014229024 | Producer of Sterile and Non Sterile Drug Products | Texas, United States | Sep 5, 2025 | FDA |
| Immacule Lifesciences Private Limited | 3014210753 | Sterile Drug Manufacturer | India | Sep 18, 2025 | FDA |
| Fareva Amboise | 3000234005 | Sterile Drug Manufacturer | France | Sep 16, 2025 | FDA |
| Dr. Reddy's Laboratories | 3002807544 | Active Pharmaceutical Ingredient Manufacturer | United Kingdom | Sep 5, 2025 | FDA |
| Aurobindo Pharma Ltd. Unit-XII | 3004446312 | Drug Manufacturer | India | Sep 5, 2025 | FDA |
| Dr. Reddy’s Laboratories, LTD, Biologics | 3014250111 | Drug Substance Intermediate Manufacturer | India | Sep 12, 2025 | FDA |