FDA Inspection 990191 — GP Grenzach Produktions GmbH
The FDA completed an inspection of GP Grenzach Produktions GmbH on Jul 1, 2016 in Grenzach-Wyhlen. 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). 11 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 1, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grenzach-Wyhlen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 9081 | 21 CFR 600.12(c) | Sterilization of Equipment and Supplies |
| 9933 | 21 CFR 120.6(b) | GMP correction - timely |