FDA Inspection 916685 — Pierre Fabre Dermo Cosmetique
The FDA completed an inspection of Pierre Fabre Dermo Cosmetique on Jan 16, 2015 in Avene. 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
- Jan 16, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Avene (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |