FDA Inspection 1109239 — Gland Pharma Limited
The FDA completed an inspection of Gland Pharma Limited on Nov 7, 2019 in Sangareddy district, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 7, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sangareddy district, Hyderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |