1152299
Health Pharma USA LLC — FEI 3013856804
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rahway, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2397 | 21 CFR 211.194(a)(1) | Description and Identification of Samples |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |