FDA Inspection 737215 — Fareva Unterach GmbH
The FDA completed an inspection of Fareva Unterach GmbH on July 25, 2011 in Unterach Am Attersee. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Unterach Am Attersee (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |