FDA 483 Database
FDA Form 483s Issued in 2023
Every published Form FDA 483 issued in 2023, 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.
97
Published 483s in 2023
12
Months with records
Browse 2023 by month
Most recent Form 483s in 2023
Showing 25 of 97 — open a month above for the full list.
Fujian Genohope Biotech LtdFDA
- FEI
- 3025263427
- Issued
- Jun 2, 2023
- Establishment
- Sterile Drug Manufacturer
- Location
- China
BlendHouse LLCFDA
- FEI
- 3015728839
- Issued
- Feb 17, 2023
- Establishment
- Manufacturer
- Location
- Pennsylvania, United States
Sanofi S.p.A.FDA
- FEI
- 3002807108
- Issued
- May 22, 2023
- Establishment
- Drug Manufacturer
- Location
- Italy
Laboratorios Farmaceuticos Rovi S. A.FDA
- FEI
- 3010705046
- Issued
- May 19, 2023
- Establishment
- Sterile Drug Manufacturer
- Location
- Spain
Suzhou Suncadia Biopharmaceutical CO., Ltd.FDA
- FEI
- 3015786877
- Issued
- Dec 14, 2023
- Establishment
- Drug Substance Intermediate Manufacturer
- Location
- China
Eli Lilly and CompanyFDA
- FEI
- 1819470
- Issued
- Oct 6, 2023
- Establishment
- Drug Manufacturer
- Location
- United States
Oishi Koseido Co., Ltd.FDA
- FEI
- 3010166685
- Issued
- Sep 1, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Japan
Daizo CorporationFDA
- FEI
- 3008470621
- Issued
- Nov 6, 2023
- Establishment
- OTC Drug Manufacturer
- Location
- Japan
Wuxi Biologics Co., Ltd.FDA
- FEI
- 3010606982
- Issued
- May 9, 2023
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- China
Dr. Reddy's Laboratories Ltd., BiologicsFDA
- FEI
- 3014250111
- Issued
- Oct 12, 2023
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- India
Rovi Pharma Industrial Services S.A.FDA
- FEI
- 3016688535
- Issued
- Sep 22, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Spain
Zhejiang Peptides Biotech Co, Ltd.FDA
- FEI
- 3015685285
- Issued
- Sep 7, 2023
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- China
Amman Pharmaceutical IndustriesFDA
- FEI
- 3013501887
- Issued
- Aug 15, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Jordan
Fresenius Kabi Oncology LimitedFDA
- FEI
- 3006210232
- Issued
- Oct 10, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- India
Patheon Italia S.p.A.FDA
- FEI
- 3003065803
- Issued
- May 26, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Italy
Apicore Pharmaceuticals Private Ltd.FDA
- FEI
- 3006767695
- Issued
- May 5, 2023
- Establishment
- Human Drug Manufacturer
- Location
- India
Regeneron Ireland Designated Activity CompanyFDA
- FEI
- 3011684330
- Issued
- Mar 14, 2023
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Ireland
Takeda Pharmaceutical Company, LimitedFDA
- FEI
- 3004664162
- Issued
- Nov 6, 2023
- Establishment
- Human Drug Manufacturer
- Location
- Japan
Astellas Pharma Inc.FDA
- FEI
- 3002809620
- Issued
- Oct 27, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Japan
Jubilant HollisterStier General PartnershipFDA
- FEI
- 3001623073
- Issued
- Feb 28, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Canada
Nanchang Anobri Pharmaceutical Co., Ltd.FDA
- FEI
- 3023765884
- Issued
- Nov 21, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- China
Aqualex Co., Ltd.FDA
- FEI
- 3010683345
- Issued
- Oct 20, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Republic of Korea
TERUMO YAMAGUCHI CORPORATIONFDA
- FEI
- 3013611763
- Issued
- Mar 30, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Japan
Samsung Bioepis Co., Ltd.FDA
- FEI
- 3010031951
- Issued
- Sep 15, 2023
- Establishment
- Sponsor
- Location
- Republic of Korea
Eisai CompanyFDA
- FEI
- 3004967045
- Issued
- Oct 27, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Japan
| Company | FEI | Establishment type | Location | Issued | Source |
|---|---|---|---|---|---|
| Fujian Genohope Biotech Ltd | 3025263427 | Sterile Drug Manufacturer | China | Jun 2, 2023 | FDA |
| BlendHouse LLC | 3015728839 | Manufacturer | Pennsylvania, United States | Feb 17, 2023 | FDA |
| Sanofi S.p.A. | 3002807108 | Drug Manufacturer | Italy | May 22, 2023 | FDA |
| Laboratorios Farmaceuticos Rovi S. A. | 3010705046 | Sterile Drug Manufacturer | Spain | May 19, 2023 | FDA |
| Suzhou Suncadia Biopharmaceutical CO., Ltd. | 3015786877 | Drug Substance Intermediate Manufacturer | China | Dec 14, 2023 | FDA |
| Eli Lilly and Company | 1819470 | Drug Manufacturer | United States | Oct 6, 2023 | FDA |
| Oishi Koseido Co., Ltd. | 3010166685 | Finished Pharmaceutical Manufacturer | Japan | Sep 1, 2023 | FDA |
| Daizo Corporation | 3008470621 | OTC Drug Manufacturer | Japan | Nov 6, 2023 | FDA |
| Wuxi Biologics Co., Ltd. | 3010606982 | Active Pharmaceutical Ingredient Manufacturer | China | May 9, 2023 | FDA |
| Dr. Reddy's Laboratories Ltd., Biologics | 3014250111 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | India | Oct 12, 2023 | FDA |
| Rovi Pharma Industrial Services S.A. | 3016688535 | Finished Pharmaceutical Manufacturer | Spain | Sep 22, 2023 | FDA |
| Zhejiang Peptides Biotech Co, Ltd. | 3015685285 | Active Pharmaceutical Ingredient Manufacturer | China | Sep 7, 2023 | FDA |
| Amman Pharmaceutical Industries | 3013501887 | Finished Pharmaceutical Manufacturer | Jordan | Aug 15, 2023 | FDA |
| Fresenius Kabi Oncology Limited | 3006210232 | Finished Pharmaceutical Manufacturer | India | Oct 10, 2023 | FDA |
| Patheon Italia S.p.A. | 3003065803 | Finished Pharmaceutical Manufacturer | Italy | May 26, 2023 | FDA |
| Apicore Pharmaceuticals Private Ltd. | 3006767695 | Human Drug Manufacturer | India | May 5, 2023 | FDA |
| Regeneron Ireland Designated Activity Company | 3011684330 | Active Pharmaceutical Ingredient Manufacturer | Ireland | Mar 14, 2023 | FDA |
| Takeda Pharmaceutical Company, Limited | 3004664162 | Human Drug Manufacturer | Japan | Nov 6, 2023 | FDA |
| Astellas Pharma Inc. | 3002809620 | Finished Pharmaceutical Manufacturer | Japan | Oct 27, 2023 | FDA |
| Jubilant HollisterStier General Partnership | 3001623073 | Finished Pharmaceutical Manufacturer | Canada | Feb 28, 2023 | FDA |
| Nanchang Anobri Pharmaceutical Co., Ltd. | 3023765884 | Finished Pharmaceutical Manufacturer | China | Nov 21, 2023 | FDA |
| Aqualex Co., Ltd. | 3010683345 | Finished Pharmaceutical Manufacturer | Republic of Korea | Oct 20, 2023 | FDA |
| TERUMO YAMAGUCHI CORPORATION | 3013611763 | Finished Pharmaceutical Manufacturer | Japan | Mar 30, 2023 | FDA |
| Samsung Bioepis Co., Ltd. | 3010031951 | Sponsor | Republic of Korea | Sep 15, 2023 | FDA |
| Eisai Company | 3004967045 | Finished Pharmaceutical Manufacturer | Japan | Oct 27, 2023 | FDA |