FDA Inspection 1216053 — Gland Pharma Limited
The FDA completed an inspection of Gland Pharma Limited on August 26, 2023 in Sangareddy district, Hyderabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 26, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sangareddy district, Hyderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 3175 | 21 CFR 820.186 | QSR |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |