FDA Inspection 789195 — Unichem Laboratories Ltd.
The FDA completed an inspection of Unichem Laboratories Ltd. on Jun 15, 2012 in Ghaziabad. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 15, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ghaziabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |