FDA Inspection 1057350 — Unichem Laboratories Limited
The FDA completed an inspection of Unichem Laboratories Limited on Jun 29, 2018 in Mumbai. 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
- Jun 29, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Mumbai (India)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6842 | 21 CFR 314.80(j) | Failure to maintain records |