1218305
International Trading Pharm Lab Inc — FEI 1000208853
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paterson, NJ (United States)
Citations
| ID | CFR | Description |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |