1217129
IDT Biologika GmbH — FEI 3005001757
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Dessau-Rosslau (Germany)
Citations
| ID | CFR | Description |
|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |
| 9326 | 21 CFR 610.1 | Tests prior to release |