FDA Inspection 1084595 — Sun Pharmaceutical Industries Limited
The FDA completed an inspection of Sun Pharmaceutical Industries Limited on March 29, 2019 in Dadra. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dadra (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3566 | 21 CFR 211.84(c)(4) | Composite sample top/middle/bottom |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |