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844890

Amgen Manufacturing Limited LLC — FEI 1000110364

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 15, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
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))
  • 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))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance