FDA Inspection 962557 — Glenmark Pharmaceuticals Limited
The FDA completed an inspection of Glenmark Pharmaceuticals Limited on February 26, 2016 in Dhar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 26, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dhar (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |