FDA Inspection 985371 — Cosmetique Active Production
The FDA completed an inspection of Cosmetique Active Production on Sep 2, 2016 in Creuzier-Le-Vieux. 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). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 2, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Creuzier-Le-Vieux (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2400 | 21 CFR 211.194(a)(3) | Statement of Sample Weights and Measures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |