1018900
Legacy Pharmaceuticals Switzerland GmbH — FEI 3007457560
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 21, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Birsfelden (Switzerland)
Citations
| ID | CFR | Description |
|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |