1034625
Gopaldas Visram & Company Ltd. — FEI 3009565091
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 1, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Navi Mumbai (India)
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 |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3558 | 21 CFR 211.52 | Washing and toilet facilities not provided and accessible |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |