FDA Inspection 1118644 — Granules India Limited
The FDA completed an inspection of Granules India Limited on Feb 14, 2020 in Medchal-Malkhajgiri District. 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
- Feb 14, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Medchal-Malkhajgiri District (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |