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892913

Alexion Pharmaceuticals, Inc. — FEI 3006568549

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 22, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Smithfield, RI (United States)

Facility

Other inspections at this facility

  • 1019062 (VAI Fri Jul 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984855 (VAI Wed Aug 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 938440 (VAI Wed Aug 12 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 710477 (VAI Fri Feb 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113421 CFR 211.25(b)Supervisor Training/Education/Experience
145021 CFR 211.113(a)Procedures for non-sterile drug products