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967270

Westwood Laboratories, LLC. — FEI 2020372

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 5, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Azusa, CA (United States)

Facility

Other inspections at this facility

  • 1253079 (OAI Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1223194 (OAI Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1168736 (VAI Tue Apr 05 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098876 (VAI Fri Aug 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091187 (VAI Thu May 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
181021 CFR 211.160(a)Lab controls established, including changes
191221 CFR 211.166(a)Written program not followed
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved