FDA Inspection 1244548 — Gland Pharma Limited
The FDA completed an inspection of Gland Pharma Limited on Jul 25, 2024 in Hyderabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 25, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hyderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |