FDA Inspection 895756 — Zydus Lifesciences Limited
The FDA completed an inspection of Zydus Lifesciences Limited on Sep 5, 2014 in Ahmedabad. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 5, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- 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 |