Home / Inspections / 658294

658294

Alexion Pharmaceuticals, Inc. — FEI 3006031727

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 21, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
New Haven, CT (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

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
241921 CFR 211.198(a)Complaint Handling Procedure
673021 CFR 314.80(b)Failure to develop written procedures