994505
IDT Biologika GmbH — FEI 3005001757
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 22, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dessau-Rosslau (Germany)
Citations
| ID | CFR | Description |
|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 4576 | 21 CFR 211.192 | No written record of investigation |