1092057
Health Pharma USA LLC — FEI 3013856804
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 3, 2019
- Fiscal Year
- 2019
- 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 |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |