FDA Inspection 1181478 — Laboratoires Clarins
The FDA completed an inspection of Laboratoires Clarins on October 14, 2022 in Pontoise. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 14, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pontoise (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |