895756
Zydus Lifesciences Limited — FEI 3002984011
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 5, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Taluka Sanand, Ahmedabad (India)
Citations
| ID | CFR | Description |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 8906 | 21 CFR 314.81(b)(1)(i) | Mix-up |