800507
Gland Pharma Limited — FEI 3002647489
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hyderabad (India)
Citations
| ID | CFR | Description |
|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |