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1253079

Westwood Laboratories, LLC. — FEI 2020372

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 31, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Azusa, CA (United States)

Facility

Other inspections at this facility

  • 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))
  • 1078712 (NAI Wed Jan 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
183321 CFR 211.84(d)(1)Identity Testing of Each Component
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs