FDA Inspection 697468 — Genlabs Corporation
The FDA completed an inspection of Genlabs Corporation on Nov 10, 2010 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 10, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chino, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |