FDA Inspection 744219 — Fareva Amboise
The FDA completed an inspection of Fareva Amboise on Sep 20, 2011 in Poce Sur Cisse. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 20, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Poce Sur Cisse (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |