FDA Inspection 967270 — Westwood Laboratories, LLC.
The FDA completed an inspection of Westwood Laboratories, LLC. on Feb 5, 2016 in Azusa, 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). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 5, 2016
- Fiscal Year
- 2016
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Azusa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |