FDA Inspection 1167325 — Western Chemical Inc.
The FDA completed an inspection of Western Chemical Inc. on April 14, 2022 in Ferndale, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2022
- Fiscal Year
- 2022
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Ferndale, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2015 | 21 CFR 211.188(b)(3) | Identification of Components and In-Process Materials |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |