FDA Inspection 822974 — West Agro, Inc
The FDA completed an inspection of West Agro, Inc on February 21, 2013 in Des Plaines, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Des Plaines, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4416 | 21 CFR 211.204 | Reprocessed returned drug products |