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
19
Distinct firms
Form 483s issued in September 2025
Intas Pharmaceutical LimitedFDA
- FEI
- 3005890633
- Issued
- Sep 17, 2025
- Establishment
- Drug Product Manufacturer
- Location
- India
Zydus Lifesciences LimitedFDA
- FEI
- 3013712903
- Issued
- Sep 5, 2025
- Establishment
- Sterile Drug Manufacturer
- Location
- India
Baxter Oncology GmbHFDA
- FEI
- 3002806419
- Issued
- Sep 26, 2025
- Establishment
- Drug Manufacturer
- Location
- Germany
Petscript IncFDA
- FEI
- 3010282564
- Issued
- Sep 18, 2025
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Texas, United States
Lupin LimitedFDA
- FEI
- 3015392060
- Issued
- Sep 16, 2025
- Establishment
- Sterile Drug Manufacturer
- Location
- India
Qualgen LLCFDA
- FEI
- 3011286349
- Issued
- Sep 4, 2025
- Establishment
- Outsourcing Facility
- Location
- Oklahoma, United States
Biocon Biologics LimitedFDA
- FEI
- 3015283245
- Issued
- Sep 3, 2025
- Establishment
- Drug Manufacturer
- Location
- India
Sun Pharmaceuticals Medicare Ltd.FDA
- FEI
- 3002957541
- Issued
- Sep 19, 2025
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- India
ProRx LLCFDA
- FEI
- 3022250654
- Issued
- Sep 19, 2025
- Establishment
- Outsourcing Facility
- Location
- Pennsylvania, United States
Park Avenue CompoundingFDA
- FEI
- 1972829
- Issued
- Sep 23, 2025
- Establishment
- Outsourcing Facility
- Location
- Missouri, United States
Central Admixture Pharmacy Services IncFDA
- FEI
- 3009590582
- Issued
- Sep 5, 2025
- Establishment
- Outsourcing Facility
- Location
- Pennsylvania, United States
Farmakeio Outsourcing LLCFDA
- FEI
- 3014982757
- Issued
- Sep 5, 2025
- Establishment
- Outsourcing Facility
- Location
- Texas, United States
Central Admixture Pharmacy Services IncFDA
- FEI
- 3014307835
- Issued
- Sep 5, 2025
- Establishment
- Outsourcing Facility
- Location
- Arizona, United States
North American Custom Laboratories LLCFDA
- FEI
- 3014229024
- Issued
- Sep 5, 2025
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Texas, United States
Fareva AmboiseFDA
- FEI
- 3000234005
- Issued
- Sep 16, 2025
- Establishment
- Sterile Drug Manufacturer
- Location
- France
Immacule Lifesciences Private LimitedFDA
- FEI
- 3014210753
- Issued
- Sep 18, 2025
- Establishment
- Sterile Drug Manufacturer
- Location
- India
Dr. Reddy's LaboratoriesFDA
- FEI
- 3002807544
- Issued
- Sep 5, 2025
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- United Kingdom
Aurobindo Pharma Ltd. Unit-XIIFDA
- FEI
- 3004446312
- Issued
- Sep 5, 2025
- Establishment
- Drug Manufacturer
- Location
- India
Dr. Reddy’s Laboratories, LTD, BiologicsFDA
- FEI
- 3014250111
- Issued
- Sep 12, 2025
- Establishment
- Drug Substance Intermediate Manufacturer
- Location
- India
| 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 |
| Fareva Amboise | 3000234005 | Sterile Drug Manufacturer | France | Sep 16, 2025 | FDA |
| Immacule Lifesciences Private Limited | 3014210753 | Sterile Drug Manufacturer | India | Sep 18, 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 |