1101849
NEW WORLD HEALTHCARE PRIVATE LIMITED — FEI 3014616341
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 13, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mehsana (India)
Citations
| ID | CFR | Description |
|---|
| 1724 | 21 CFR 211.134(b) | Representative samples after completion |
| 2001 | 21 CFR 211.184(b) | Component Test Records |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |