FDA Inspection 1043371 — Gland Pharma Limited
The FDA completed an inspection of Gland Pharma Limited on Feb 23, 2018 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
- Feb 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sangareddy district, Hyderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |