FDA Inspection 759172 — Sun Pharmaceutical Industries, LTD.
The FDA completed an inspection of Sun Pharmaceutical Industries, LTD. on December 14, 2011 in Wixom, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 14, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wixom, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4576 | 21 CFR 211.192 | No written record of investigation |