FDA Inspection 942862 — Farmea
The FDA completed an inspection of Farmea on Jun 12, 2015 in Angers Cedex 01. 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
- Jun 12, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Angers Cedex 01 (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |