FDA Inspection 1168736 — Westwood Laboratories, LLC.

Westwood Laboratories, LLC. — FEI 2020372

The FDA completed an inspection of Westwood Laboratories, LLC. on April 5, 2022 in Azusa, CA. 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 5, 2022
Fiscal Year
2022
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Azusa, CA (United States)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
145021 CFR 211.113(a)Procedures for non-sterile drug products
200921 CFR 211.188Prepared for each batch, include complete information
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved