FDA Inspection 811365 — Cenexi
The FDA completed an inspection of Cenexi on Dec 11, 2012 in Fontenay-Sous-Bois. 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
- Dec 11, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fontenay-Sous-Bois (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4576 | 21 CFR 211.192 | No written record of investigation |