990453
F. Hoffmann - La Roche Ltd. — FEI 3003973536
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 13, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kaiseraugst (Switzerland)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |