FDA Inspection 1015447 — Sentiss Pharma Private Ltd.
The FDA completed an inspection of Sentiss Pharma Private Ltd. on May 23, 2017 in District Solan. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 23, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- District Solan (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |