FDA Inspection 1091187 — Westwood Laboratories, LLC.

Westwood Laboratories, LLC. — FEI 2020372

The FDA completed an inspection of Westwood Laboratories, LLC. on May 30, 2019 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). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
May 30, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
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
181021 CFR 211.160(a)Lab controls established, including changes

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.