FDA Inspection 1102945 — Pierre Fabre Dermo Cosmetique
The FDA completed an inspection of Pierre Fabre Dermo Cosmetique on Sep 20, 2019 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 20, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Avene (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |