FDA Inspection 940945 — Recipharm Monts
The FDA completed an inspection of Recipharm Monts on Jun 9, 2015 in Monts. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 9, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monts (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |