FDA Inspection 855547 — Sun Pharmaceutical Industries Limited - Karkhadi
The FDA completed an inspection of Sun Pharmaceutical Industries Limited - Karkhadi on November 16, 2013 in Padra. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 16, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Padra (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 939 | 21 CFR 123.9(f) | Computerized records |