FDA Inspection 1042525 — Sun Pharmaceutical Industries Ltd.
The FDA completed an inspection of Sun Pharmaceutical Industries Ltd. on February 23, 2018 in Halol. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Halol (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |