Home / Inspections / 1016325

1016325

Amgen Manufacturing Limited LLC — FEI 1000110364

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 10, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Juncos, PR (United States)

Facility

Other inspections at this facility

  • 1209484 (VAI Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 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
194321 CFR 211.180(e)(1)Review of representative number of batches
438821 CFR 211.198(a)Complaints reviewed by Quality Control Unit