FDA Inspection 1006001 — Sanofi-Aventis Deutschland GmbH
The FDA completed an inspection of Sanofi-Aventis Deutschland GmbH on Mar 3, 2017 in Frankfurt Am Main. 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
- Mar 3, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Frankfurt Am Main (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |