FDA Inspection 1092166 — Sentiss Pharma Private Ltd.
The FDA completed an inspection of Sentiss Pharma Private Ltd. on May 14, 2019 in District Solan. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 14, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- District Solan (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |