FDA Inspection 885746 — Fareva Mirabel
The FDA completed an inspection of Fareva Mirabel on May 22, 2014 in Riom. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 22, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Riom (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |