FDA Inspection 1018720 — Amoli Organics (A Division of Umedica Laboratories Pvt Ltd)
The FDA completed an inspection of Amoli Organics (A Division of Umedica Laboratories Pvt Ltd) on March 31, 2017 in Vapi. 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
- March 31, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vapi (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |