FDA Inspection 907461 — Laboratoires Clarins
The FDA completed an inspection of Laboratoires Clarins on Nov 21, 2014 in Pontoise. 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
- Nov 21, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pontoise (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 4311 | 21 CFR 211.84(c)(4) | Compositing of Sub Samples |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |