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 Mar 31, 2017 in Vapi. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 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 |