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896663

Alexion Pharmaceuticals, Inc. — FEI 3006031727

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 26, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
New Haven, CT (United States)

Facility

Other inspections at this facility

  • 1066184 (NAI Fri Aug 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1024210 (NAI Thu Aug 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1011323 (VAI Wed Apr 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979094 (NAI Mon Jun 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 931660 (NAI Wed Jun 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683221 CFR 314.80(c)(2)Late submission of annual safety reports