FDA Inspection 1039362 — GP Grenzach Produktions GmbH
The FDA completed an inspection of GP Grenzach Produktions GmbH on Jan 30, 2018 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 30, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grenzach-Wyhlen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |