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1254018

Alexion Pharmaceuticals, Inc. — FEI 3014801948

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 7, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Boston, MA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1262947 (VAI Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1219061 (NAI Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1218199 (NAI Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1160097 (NAI Fri Dec 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1802521 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR
672821 CFR 314.80(b)Failure to review ADE information
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report