FDA Inspection 872367 — Fareva Amboise
The FDA completed an inspection of Fareva Amboise on Mar 18, 2014 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 18, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Poce Sur Cisse (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4380 | 21 CFR 211.198(b)(3) | Determination not to conduct investigation of complaint |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |