906482
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 10, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lakewood, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |