FDA Inspection 1155063 — Regeneron Pharmaceuticals Inc
The FDA completed an inspection of Regeneron Pharmaceuticals Inc on October 25, 2021 in Rensselaer, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rensselaer, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 9089 | 21 CFR 600.14(c) | When to report |