1227225
Xiamen Tiger Medical Co., Ltd. — FEI 3012323390
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 19, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Xiamen (China)
Citations
| ID | CFR | Description |
|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |