FDA Inspection 955347 — Fareva Mirabel
The FDA completed an inspection of Fareva Mirabel on Jan 19, 2016 in Riom. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 19, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Riom (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |