FDA 483 Database
FDA Form 483s Issued in 2022
Every published Form FDA 483 issued in 2022, 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.
102
Published 483s in 2022
12
Months with records
Browse 2022 by month
Most recent Form 483s in 2022
Showing 25 of 102 — open a month above for the full list.
Revance Therapeutics, Inc.FDA
- FEI
- 3007772056
- Issued
- Jul 15, 2022
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- United States
Biocon Sdn. Bhd.FDA
- FEI
- 3011248248
- Issued
- Aug 30, 2022
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- Malaysia
Bushu Pharmaceuticals Ltd.FDA
- FEI
- 3005709762
- Issued
- Dec 2, 2022
- Establishment
- Drug Manufacturer
- Location
- Japan
Vetter Pharma-Fertigung GmbH & Co. KGFDA
- FEI
- 3005987757
- Issued
- Aug 26, 2022
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Germany
Meiji Seika Pharma Co., Ltd.FDA
- FEI
- 3008927877
- Issued
- Sep 2, 2022
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Japan
Kyowa Hakko Bio Co., Ltd.FDA
- FEI
- 3007807424
- Issued
- Apr 15, 2022
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Japan
Chunghwa Chemical Synthesis & Biotech Co., Ltd.FDA
- FEI
- 3002806677
- Issued
- Nov 18, 2022
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Taiwan
Fuji Yakuhin Co., Ltd.FDA
- FEI
- 3008538640
- Issued
- Nov 25, 2022
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Japan
Zhejiang Tianyu Pharmaceutical Co. Ltd.FDA
- FEI
- 3010972581
- Issued
- Mar 4, 2022
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- China
Laboratorios Farmaceuticos Rovi S. A.FDA
- FEI
- 3010705046
- Issued
- Jun 27, 2022
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Spain
Samsung BiologicsFDA
- FEI
- 3010479596
- Issued
- Jun 9, 2022
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- Republic of Korea
Catalent Indiana LLCFDA
- FEI
- 3005949964
- Issued
- Sep 1, 2022
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- United States
SentaraFDA
- FEI
- 3011627411
- Issued
- Dec 16, 2022
- Establishment
- Producer of Sterile Drug Products
- Location
- Virginia, United States
MSLS LLC dba The Medicine ShoppeFDA
- FEI
- 3012814943
- Issued
- Sep 28, 2022
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Missouri, United States
iRhythm TechnologiesFDA
- FEI
- 3021769057
- Issued
- Aug 12, 2022
- Establishment
- Medical Device Manufacturer
- Location
- California, United States
Nephron PharmaceuticalsFDA
- FEI
- 3010247115
- Issued
- Dec 2, 2022
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Kentucky, United States
Eli Lilly and CompanyFDA
- FEI
- 1819470
- Issued
- Oct 21, 2022
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- United States
QuVa Pharma, Inc.FDA
- FEI
- 3012053582
- Issued
- Aug 18, 2022
- Establishment
- Outsourcing Facility
- Location
- Texas, United States
CareFirst Specialty Pharmacy LLCFDA
- FEI
- 3012258924
- Issued
- Nov 30, 2022
- Establishment
- Producer of Non Sterile Drug Products
- Location
- New Jersey, United States
Barclay, Luke, & Pillai Specialty Pharmacy, PLLCFDA
- FEI
- 3011888866
- Issued
- Dec 9, 2022
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Nevada, United States
Amneal Pharmaceuticals Private Ltd.FDA
- FEI
- 3010254278
- Issued
- Dec 23, 2022
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- India
Northern VA Compounders PLLCFDA
- FEI
- 3012590153
- Issued
- Dec 9, 2022
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Virginia, United States
RC Outsourcing LLCFDA
- FEI
- 3011967886
- Issued
- Sep 23, 2022
- Establishment
- Outsourcing Facility
- Location
- Ohio, United States
Wells Pharma of Houston LLCFDA
- FEI
- 3016710931
- Issued
- Dec 14, 2022
- Establishment
- Outsourcing Facility
- Location
- Texas, United States
PQ Pharmacy LLCFDA
- FEI
- 3017374013
- Issued
- Oct 27, 2022
- Establishment
- Outsourcing Facility
- Location
- Florida, United States
| Company | FEI | Establishment type | Location | Issued | Source |
|---|---|---|---|---|---|
| Revance Therapeutics, Inc. | 3007772056 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | United States | Jul 15, 2022 | FDA |
| Biocon Sdn. Bhd. | 3011248248 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | Malaysia | Aug 30, 2022 | FDA |
| Bushu Pharmaceuticals Ltd. | 3005709762 | Drug Manufacturer | Japan | Dec 2, 2022 | FDA |
| Vetter Pharma-Fertigung GmbH & Co. KG | 3005987757 | Finished Pharmaceutical Manufacturer | Germany | Aug 26, 2022 | FDA |
| Meiji Seika Pharma Co., Ltd. | 3008927877 | Active Pharmaceutical Ingredient Manufacturer | Japan | Sep 2, 2022 | FDA |
| Kyowa Hakko Bio Co., Ltd. | 3007807424 | Active Pharmaceutical Ingredient Manufacturer | Japan | Apr 15, 2022 | FDA |
| Chunghwa Chemical Synthesis & Biotech Co., Ltd. | 3002806677 | Active Pharmaceutical Ingredient Manufacturer | Taiwan | Nov 18, 2022 | FDA |
| Fuji Yakuhin Co., Ltd. | 3008538640 | Finished Pharmaceutical Manufacturer | Japan | Nov 25, 2022 | FDA |
| Zhejiang Tianyu Pharmaceutical Co. Ltd. | 3010972581 | Active Pharmaceutical Ingredient Manufacturer | China | Mar 4, 2022 | FDA |
| Laboratorios Farmaceuticos Rovi S. A. | 3010705046 | Finished Pharmaceutical Manufacturer | Spain | Jun 27, 2022 | FDA |
| Samsung Biologics | 3010479596 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | Republic of Korea | Jun 9, 2022 | FDA |
| Catalent Indiana LLC | 3005949964 | Finished Pharmaceutical Manufacturer | United States | Sep 1, 2022 | FDA |
| Sentara | 3011627411 | Producer of Sterile Drug Products | Virginia, United States | Dec 16, 2022 | FDA |
| MSLS LLC dba The Medicine Shoppe | 3012814943 | Producer of Non Sterile Drug Products | Missouri, United States | Sep 28, 2022 | FDA |
| iRhythm Technologies | 3021769057 | Medical Device Manufacturer | California, United States | Aug 12, 2022 | FDA |
| Nephron Pharmaceuticals | 3010247115 | Producer of Sterile and Non Sterile Drug Products | Kentucky, United States | Dec 2, 2022 | FDA |
| Eli Lilly and Company | 1819470 | Finished Pharmaceutical Manufacturer | United States | Oct 21, 2022 | FDA |
| QuVa Pharma, Inc. | 3012053582 | Outsourcing Facility | Texas, United States | Aug 18, 2022 | FDA |
| CareFirst Specialty Pharmacy LLC | 3012258924 | Producer of Non Sterile Drug Products | New Jersey, United States | Nov 30, 2022 | FDA |
| Barclay, Luke, & Pillai Specialty Pharmacy, PLLC | 3011888866 | Producer of Sterile and Non Sterile Drug Products | Nevada, United States | Dec 9, 2022 | FDA |
| Amneal Pharmaceuticals Private Ltd. | 3010254278 | Finished Pharmaceutical Manufacturer | India | Dec 23, 2022 | FDA |
| Northern VA Compounders PLLC | 3012590153 | Producer of Non Sterile Drug Products | Virginia, United States | Dec 9, 2022 | FDA |
| RC Outsourcing LLC | 3011967886 | Outsourcing Facility | Ohio, United States | Sep 23, 2022 | FDA |
| Wells Pharma of Houston LLC | 3016710931 | Outsourcing Facility | Texas, United States | Dec 14, 2022 | FDA |
| PQ Pharmacy LLC | 3017374013 | Outsourcing Facility | Florida, United States | Oct 27, 2022 | FDA |