FDA Inspection 967376 — Simtra Deutschland GmbH
The FDA completed an inspection of Simtra Deutschland GmbH on Mar 18, 2016 in Halle (Westf.). 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 18, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Halle (Westf.) (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |