FDA Inspection 992633 — Sanofi Winthrop Industrie
The FDA completed an inspection of Sanofi Winthrop Industrie on October 31, 2016 in Maisons Alfort. 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 31, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Maisons Alfort (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |