FDA Inspection 760697 — Genlabs Corporation
The FDA completed an inspection of Genlabs Corporation on Dec 9, 2011 in Chino, CA. 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
- Dec 9, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chino, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |