FDA 483 Database
FDA Form 483s Issued in March 2023
Every published Form FDA 483 issued in March 2023, drawn from the FDA OII FOIA Electronic Reading Room. Each row links to the FDA source record.
18
Published 483s in March 2023
17
Distinct firms
Form 483s issued in March 2023
Regeneron Ireland Designated Activity CompanyFDA
- FEI
- 3011684330
- Issued
- Mar 14, 2023
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Ireland
TERUMO YAMAGUCHI CORPORATIONFDA
- FEI
- 3013611763
- Issued
- Mar 30, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Japan
Hugel, Inc.FDA
- FEI
- 3012163998
- Issued
- Mar 10, 2023
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- Republic of Korea
Lonza AGFDA
- FEI
- 3002930340
- Issued
- Mar 28, 2023
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Switzerland
Spectrum Laboratory ProductsFDA
- FEI
- 2246824
- Issued
- Mar 24, 2023
- Establishment
- Repacker/Relabeler
- Location
- United States
SNF Holdings LLCFDA
- FEI
- 3021886842
- Issued
- Mar 2, 2023
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Michigan, United States
Central AdmixtureFDA
- FEI
- 3009590582
- Issued
- Mar 30, 2023
- Establishment
- Outsourcing Facility
- Location
- Pennsylvania, United States
Wuxi STA Pharmaceutical Co. Ltd.FDA
- FEI
- 3014784835
- Issued
- Mar 3, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- China
Fresenius KabiFDA
- FEI
- 3013438665
- Issued
- Mar 6, 2023
- Establishment
- Outsourcing Facility
- Location
- Massachusetts, United States
Palisades Compounding PharmacyFDA
- FEI
- 3008174851
- Issued
- Mar 15, 2023
- Establishment
- Producer of Non Sterile Drug Products
- Location
- California, United States
Maimonides Medical CenterFDA
- FEI
- 3015468054
- Issued
- Mar 9, 2023
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- New York, United States
Prisma HealthFDA
- FEI
- 3015162096
- Issued
- Mar 3, 2023
- Establishment
- Outsourcing Facility
- Location
- South Carolina, United States
Rentschler Biopharma SEFDA
- FEI
- 1000291122
- Issued
- Mar 7, 2023
- Establishment
- Drug Substance Intermediate Manufacturer
- Location
- Germany
Alvotech HfFDA
- FEI
- 3013702557
- Issued
- Mar 17, 2023
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- Iceland
Lupin LimitedFDA
- FEI
- 3007549629
- Issued
- Mar 29, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- India
Lupin LimitedFDA
- FEI
- 3007549629
- Issued
- Mar 29, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- India
Global Pharma Healthcare Ltd.FDA
- FEI
- 3012323885
- Issued
- Mar 2, 2023
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- India
Japan Food Research LaboratoriesFDA
- FEI
- 3004579906
- Issued
- Mar 29, 2023
- Establishment
- 02/24/2025
- Location
- Japan
| Company | FEI | Establishment type | Location | Issued | Source |
|---|---|---|---|---|---|
| Regeneron Ireland Designated Activity Company | 3011684330 | Active Pharmaceutical Ingredient Manufacturer | Ireland | Mar 14, 2023 | FDA |
| TERUMO YAMAGUCHI CORPORATION | 3013611763 | Finished Pharmaceutical Manufacturer | Japan | Mar 30, 2023 | FDA |
| Hugel, Inc. | 3012163998 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | Republic of Korea | Mar 10, 2023 | FDA |
| Lonza AG | 3002930340 | Active Pharmaceutical Ingredient Manufacturer | Switzerland | Mar 28, 2023 | FDA |
| Spectrum Laboratory Products | 2246824 | Repacker/Relabeler | United States | Mar 24, 2023 | FDA |
| SNF Holdings LLC | 3021886842 | Producer of Non Sterile Drug Products | Michigan, United States | Mar 2, 2023 | FDA |
| Central Admixture | 3009590582 | Outsourcing Facility | Pennsylvania, United States | Mar 30, 2023 | FDA |
| Wuxi STA Pharmaceutical Co. Ltd. | 3014784835 | Finished Pharmaceutical Manufacturer | China | Mar 3, 2023 | FDA |
| Fresenius Kabi | 3013438665 | Outsourcing Facility | Massachusetts, United States | Mar 6, 2023 | FDA |
| Palisades Compounding Pharmacy | 3008174851 | Producer of Non Sterile Drug Products | California, United States | Mar 15, 2023 | FDA |
| Maimonides Medical Center | 3015468054 | Producer of Sterile and Non Sterile Drug Products | New York, United States | Mar 9, 2023 | FDA |
| Prisma Health | 3015162096 | Outsourcing Facility | South Carolina, United States | Mar 3, 2023 | FDA |
| Rentschler Biopharma SE | 1000291122 | Drug Substance Intermediate Manufacturer | Germany | Mar 7, 2023 | FDA |
| Alvotech Hf | 3013702557 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | Iceland | Mar 17, 2023 | FDA |
| Lupin Limited | 3007549629 | Finished Pharmaceutical Manufacturer | India | Mar 29, 2023 | FDA |
| Lupin Limited | 3007549629 | Finished Pharmaceutical Manufacturer | India | Mar 29, 2023 | FDA |
| Global Pharma Healthcare Ltd. | 3012323885 | Finished Pharmaceutical Manufacturer | India | Mar 2, 2023 | FDA |
| Japan Food Research Laboratories | 3004579906 | 02/24/2025 | Japan | Mar 29, 2023 | FDA |