FDA Inspection 981368 — Sun Pharmaceutical Industries, Inc.
The FDA completed an inspection of Sun Pharmaceutical Industries, Inc. on Jun 29, 2016 in Billerica, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 29, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Billerica, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |