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1209484

Amgen Manufacturing Limited LLC — FEI 1000110364

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 5, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Juncos, PR (United States)

Facility

Other inspections at this facility

  • 1085900 (VAI Thu Apr 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061201 (VAI Mon Aug 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016325 (VAI Wed May 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913643 (VAI Wed Feb 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 912248 (VAI Fri Jan 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
191721 CFR 211.166(a)(1)Sample size - test intervals
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
358521 CFR 211.110(a)Control procedures to monitor and validate performance