1166834
Somerset Therapeutics Private Limited — FEI 3003821988
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 4, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bengaluru (India)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |