FDA 483 Database
FDA Form 483s Issued in 2021
Every published Form FDA 483 issued in 2021, 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.
82
Published 483s in 2021
12
Months with records
Browse 2021 by month
Most recent Form 483s in 2021
Showing 25 of 82 — open a month above for the full list.
Alembic Pharmaceuticals LimitedFDA
- FEI
- 3015685305
- Issued
- Nov 10, 2021
- Establishment
- Sterile Drug Manufacturer
- Location
- India
Alembic Pharmaceuticals LimitedFDA
- FEI
- 3015685305
- Issued
- Feb 6, 2021
- Establishment
- Sterile Pharmaceutical Manufacturer
- Location
- India
Samsung BiologicsFDA
- FEI
- 3010479596
- Issued
- Aug 24, 2021
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Republic of Korea
Front Door Pharmacy, LLCFDA
- FEI
- 3012937475
- Issued
- Jun 7, 2021
- Establishment
- Producer of Sterile Drug Products
- Location
- Texas, United States
Boothwyn Pharmacy LLCFDA
- FEI
- 1000076625
- Issued
- Sep 8, 2021
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Pennsylvania, United States
Compound Preferred LLCFDA
- FEI
- 3012465222
- Issued
- Dec 17, 2021
- Establishment
- Outsourcing Facility
- Location
- Idaho, United States
Westlab Pharmacy Inc. dba Westlab PharmacyFDA
- FEI
- 3007426960
- Issued
- Oct 5, 2021
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Florida, United States
Hugel Inc.FDA
- FEI
- 3012163998
- Issued
- Aug 20, 2021
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- South Korea
Hybrid Pharma LLCFDA
- FEI
- 3011319445
- Issued
- Sep 23, 2021
- Establishment
- Outsourcing Facility
- Location
- Florida, United States
BPI Labs LLCFDA
- FEI
- 3015156709
- Issued
- Apr 30, 2021
- Establishment
- Sterile Drug Manufacturer
- Location
- Florida, United States
Crosbys Drugs IncFDA
- FEI
- 1530045
- Issued
- Sep 30, 2021
- Establishment
- Producer of Sterile Drug Products
- Location
- Ohio, United States
STAQ Pharma, Inc.FDA
- FEI
- 3015144909
- Issued
- Sep 29, 2021
- Establishment
- Outsourcing Facility
- Location
- Colorado, United States
Apollo Care, LLCFDA
- FEI
- 3013927023
- Issued
- Sep 8, 2021
- Establishment
- Outsourcing Facility
- Location
- Missouri, United States
Qualgen LLCFDA
- FEI
- 30112866349
- Issued
- Jun 15, 2021
- Establishment
- Outsourcing Facility
- Location
- Oklahoma, United States
Bravo Packing, Inc.FDA
- FEI
- 1000121624
- Issued
- May 28, 2021
- Establishment
- Manufacturer
- Location
- New Jersey, United States
Wedgewood Connect, LLCFDA
- FEI
- 3003434972
- Issued
- Dec 3, 2021
- Establishment
- Outsourcing Facility
- Location
- California, United States
HomeChoice Partners dba BioScrip Infusion ServicesFDA
- FEI
- 3014461693
- Issued
- Aug 9, 2021
- Establishment
- Producer of Sterile Drug Products
- Location
- Georgia, United States
Abbott NutritionFDA
- FEI
- 1815692
- Issued
- Sep 24, 2021
- Establishment
- Infant Formula Manufacturer
- Location
- Michigan, United States
Hiers Enterprises, LLC dba Northwest Compounding PharmacyFDA
- FEI
- 3014745182
- Issued
- Nov 10, 2021
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Oregon, United States
LEESAR, INCFDA
- FEI
- 3010166880
- Issued
- Oct 29, 2021
- Establishment
- Outsourcing Facility
- Location
- Florida, United States
Wuxi BiologicsFDA
- FEI
- 3010606982
- Issued
- Apr 2, 2021
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- China
The Compounding PharmacyFDA
- FEI
- 3009127876
- Issued
- Sep 29, 2021
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- North Carolina, United States
New Vitalis Pharmacy LLC dba New Vitalis PharmacyFDA
- FEI
- 3014391500
- Issued
- Aug 27, 2021
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Kentucky, United States
Valgene Incorporated dba Cape DrugsFDA
- FEI
- 3004562873
- Issued
- Dec 2, 2021
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Maryland, United States
SterRx, LLCFDA
- FEI
- 3010840309
- Issued
- Nov 4, 2021
- Establishment
- Outsourcing Facility
- Location
- New York, United States
| Company | FEI | Establishment type | Location | Issued | Source |
|---|---|---|---|---|---|
| Alembic Pharmaceuticals Limited | 3015685305 | Sterile Drug Manufacturer | India | Nov 10, 2021 | FDA |
| Alembic Pharmaceuticals Limited | 3015685305 | Sterile Pharmaceutical Manufacturer | India | Feb 6, 2021 | FDA |
| Samsung Biologics | 3010479596 | Active Pharmaceutical Ingredient Manufacturer | Republic of Korea | Aug 24, 2021 | FDA |
| Front Door Pharmacy, LLC | 3012937475 | Producer of Sterile Drug Products | Texas, United States | Jun 7, 2021 | FDA |
| Boothwyn Pharmacy LLC | 1000076625 | Producer of Sterile and Non Sterile Drug Products | Pennsylvania, United States | Sep 8, 2021 | FDA |
| Compound Preferred LLC | 3012465222 | Outsourcing Facility | Idaho, United States | Dec 17, 2021 | FDA |
| Westlab Pharmacy Inc. dba Westlab Pharmacy | 3007426960 | Producer of Sterile and Non Sterile Drug Products | Florida, United States | Oct 5, 2021 | FDA |
| Hugel Inc. | 3012163998 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | South Korea | Aug 20, 2021 | FDA |
| Hybrid Pharma LLC | 3011319445 | Outsourcing Facility | Florida, United States | Sep 23, 2021 | FDA |
| BPI Labs LLC | 3015156709 | Sterile Drug Manufacturer | Florida, United States | Apr 30, 2021 | FDA |
| Crosbys Drugs Inc | 1530045 | Producer of Sterile Drug Products | Ohio, United States | Sep 30, 2021 | FDA |
| STAQ Pharma, Inc. | 3015144909 | Outsourcing Facility | Colorado, United States | Sep 29, 2021 | FDA |
| Apollo Care, LLC | 3013927023 | Outsourcing Facility | Missouri, United States | Sep 8, 2021 | FDA |
| Qualgen LLC | 30112866349 | Outsourcing Facility | Oklahoma, United States | Jun 15, 2021 | FDA |
| Bravo Packing, Inc. | 1000121624 | Manufacturer | New Jersey, United States | May 28, 2021 | FDA |
| Wedgewood Connect, LLC | 3003434972 | Outsourcing Facility | California, United States | Dec 3, 2021 | FDA |
| HomeChoice Partners dba BioScrip Infusion Services | 3014461693 | Producer of Sterile Drug Products | Georgia, United States | Aug 9, 2021 | FDA |
| Abbott Nutrition | 1815692 | Infant Formula Manufacturer | Michigan, United States | Sep 24, 2021 | FDA |
| Hiers Enterprises, LLC dba Northwest Compounding Pharmacy | 3014745182 | Producer of Non Sterile Drug Products | Oregon, United States | Nov 10, 2021 | FDA |
| LEESAR, INC | 3010166880 | Outsourcing Facility | Florida, United States | Oct 29, 2021 | FDA |
| Wuxi Biologics | 3010606982 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | China | Apr 2, 2021 | FDA |
| The Compounding Pharmacy | 3009127876 | Producer of Sterile and Non Sterile Drug Products | North Carolina, United States | Sep 29, 2021 | FDA |
| New Vitalis Pharmacy LLC dba New Vitalis Pharmacy | 3014391500 | Producer of Sterile and Non Sterile Drug Products | Kentucky, United States | Aug 27, 2021 | FDA |
| Valgene Incorporated dba Cape Drugs | 3004562873 | Producer of Sterile and Non Sterile Drug Products | Maryland, United States | Dec 2, 2021 | FDA |
| SterRx, LLC | 3010840309 | Outsourcing Facility | New York, United States | Nov 4, 2021 | FDA |