Sterigenics US, LLCFDA
- FEI
- 3001236277
- Record date
- Establishment
- Contract Sterilizer
- Location
- Texas, United States
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.
104
Published 483s in 2022
12
Months with records
Browse 2022 by month
Most recent Form 483s in 2022
Showing 25 of 104 — open a month above for the full list.
- Krispy Kreme Doughnut CorporationFDA
- FEI
- 3004794454
- Record date
- Establishment
- Manufacturer
- Location
- Ohio, United States
- Revance Therapeutics, IncFDA
- FEI
- 3007772056
- Record date
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- United States
- Biocon Sdn BhdFDA
- FEI
- 3011248248
- Record date
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- Malaysia
- UCB Pharma S.A.FDA
- FEI
- 3003909356
- Record date
- Establishment
- 03/24/2025
- Location
- Belgium
- Bushu Pharmaceuticals Ltd.FDA
- FEI
- 3005709762
- Record date
- Establishment
- Drug Manufacturer
- Location
- Japan
- Chunghwa Chemical Synthesis & Biotech Co., LtdFDA
- FEI
- 3002806677
- Record date
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Taiwan
- Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)FDA
- FEI
- 3005987757
- Record date
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Germany
- Kyowa Hakko Bio Co., Ltd.FDA
- FEI
- 3007807424
- Record date
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Japan
- Fuji Yakuhin Co., Ltd.FDA
- FEI
- 3008538640
- Record date
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Japan
- Meiji Seika Pharma Co., Ltd. - Gifu PlantFDA
- FEI
- 3008927877
- Record date
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Japan
- Zhejiang Tianyu Pharmaceutical Co LtdFDA
- FEI
- 3010972581
- Record date
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- China
- Laboratorios Farmaceuticos Rovi S. A.FDA
- FEI
- 3010705046
- Record date
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Spain
- Samsung Biologics Co., Ltd.FDA
- FEI
- 3010479596
- Record date
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- Republic of Korea
- Catalent Indiana, LLCFDA
- FEI
- 3005949964
- Record date
- Establishment
- Not posted by FDA
- Location
- Not posted by FDA
- Sentara Infusion ServicesFDA
- FEI
- 3011627411
- Record date
- Establishment
- Producer of Sterile Drug Products
- Location
- Virginia, United States
- The Medicine ShoppeFDA
- FEI
- 3012814943
- Record date
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Missouri, United States
- iRhythm Technologies, Inc.FDA
- FEI
- 3021769057
- Record date
- Establishment
- Medical Device Manufacturer
- Location
- California, United States
- Nephron PharmaceuticalsFDA
- FEI
- 3010247115
- Record date
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Kentucky, United States
- Eli Lilly & CompanyFDA
- FEI
- 1819470
- Record date
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- United States
- QuVa Pharma, Inc.FDA
- FEI
- 3012053582
- Record date
- Establishment
- Outsourcing Facility
- Location
- Texas, United States
- CareFirst Specialty Pharmacy LLCFDA
- FEI
- 3012258924
- Record date
- Establishment
- Producer of Non Sterile Drug Products
- Location
- New Jersey, United States
- Barclay, Luke, & Pillai Specialty Pharmacy, PLLCFDA
- FEI
- 3011888866
- Record date
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Nevada, United States
- Amneal Pharmaceuticals Private Ltd.FDA
- FEI
- 3010254278
- Record date
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- India
- Northern VA Compounders PLLCFDA
- FEI
- 3012590153
- Record date
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Virginia, United States
| Company | FEI | Establishment type | Location | FDA date | Source |
|---|---|---|---|---|---|
| Sterigenics US, LLC | 3001236277 | Contract Sterilizer | Texas, United States | FDA | |
| Krispy Kreme Doughnut Corporation | 3004794454 | Manufacturer | Ohio, United States | FDA | |
| Revance Therapeutics, Inc | 3007772056 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | United States | FDA | |
| Biocon Sdn Bhd | 3011248248 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | Malaysia | FDA | |
| UCB Pharma S.A. | 3003909356 | 03/24/2025 | Belgium | FDA | |
| Bushu Pharmaceuticals Ltd. | 3005709762 | Drug Manufacturer | Japan | FDA | |
| Chunghwa Chemical Synthesis & Biotech Co., Ltd | 3002806677 | Active Pharmaceutical Ingredient Manufacturer | Taiwan | FDA | |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | 3005987757 | Finished Pharmaceutical Manufacturer | Germany | FDA | |
| Kyowa Hakko Bio Co., Ltd. | 3007807424 | Active Pharmaceutical Ingredient Manufacturer | Japan | FDA | |
| Fuji Yakuhin Co., Ltd. | 3008538640 | Finished Pharmaceutical Manufacturer | Japan | FDA | |
| Meiji Seika Pharma Co., Ltd. - Gifu Plant | 3008927877 | Active Pharmaceutical Ingredient Manufacturer | Japan | FDA | |
| Zhejiang Tianyu Pharmaceutical Co Ltd | 3010972581 | Active Pharmaceutical Ingredient Manufacturer | China | FDA | |
| Laboratorios Farmaceuticos Rovi S. A. | 3010705046 | Finished Pharmaceutical Manufacturer | Spain | FDA | |
| Samsung Biologics Co., Ltd. | 3010479596 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | Republic of Korea | FDA | |
| Catalent Indiana, LLC | 3005949964 | Not posted by FDA | Not posted by FDA | FDA | |
| Sentara Infusion Services | 3011627411 | Producer of Sterile Drug Products | Virginia, United States | FDA | |
| The Medicine Shoppe | 3012814943 | Producer of Non Sterile Drug Products | Missouri, United States | FDA | |
| iRhythm Technologies, Inc. | 3021769057 | Medical Device Manufacturer | California, United States | FDA | |
| Nephron Pharmaceuticals | 3010247115 | Producer of Sterile and Non Sterile Drug Products | Kentucky, United States | FDA | |
| Eli Lilly & Company | 1819470 | Finished Pharmaceutical Manufacturer | United States | FDA | |
| QuVa Pharma, Inc. | 3012053582 | Outsourcing Facility | Texas, United States | FDA | |
| CareFirst Specialty Pharmacy LLC | 3012258924 | Producer of Non Sterile Drug Products | New Jersey, United States | FDA | |
| Barclay, Luke, & Pillai Specialty Pharmacy, PLLC | 3011888866 | Producer of Sterile and Non Sterile Drug Products | Nevada, United States | FDA | |
| Amneal Pharmaceuticals Private Ltd. | 3010254278 | Finished Pharmaceutical Manufacturer | India | FDA | |
| Northern VA Compounders PLLC | 3012590153 | Producer of Non Sterile Drug Products | Virginia, United States | FDA |