FDA Inspection 1016799 — SISLEY INDUSTRIE
The FDA completed an inspection of SISLEY INDUSTRIE on June 23, 2017 in Villebarou. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 23, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Villebarou (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |