1249754
China Pharmaceutical University — FEI 3009350497
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 20, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nanjing (China)
Citations
| ID | CFR | Description |
|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |