FDA Inspection 777063 — Westwood Laboratories, LLC.

Westwood Laboratories, LLC. — FEI 2020372

The FDA completed an inspection of Westwood Laboratories, LLC. on April 11, 2012 in Azusa, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 11, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Azusa, CA (United States)

Citations

IDCFRDescription
191221 CFR 211.166(a)Written program not followed
354521 CFR 211.44Adequate lighting not provided
358521 CFR 211.110(a)Control procedures to monitor and validate performance