FDA Inspection 1092770 — Unexo Life Sciences Private Limited
The FDA completed an inspection of Unexo Life Sciences Private Limited on May 10, 2019 in New Delhi. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- New Delhi (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |