FDA Inspection 1083394 — West Agro, Inc
The FDA completed an inspection of West Agro, Inc on March 21, 2019 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). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Des Plaines, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |