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FDA Inspection 1174738 — Genzyme Ireland Limited

Genzyme Ireland Limited — FEI 3003809840

The FDA completed an inspection of Genzyme Ireland Limited on February 25, 2022 in Waterford. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 25, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Waterford (Ireland)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1050839 (NAI Fri Feb 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015545 (VAI Fri Jun 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 944237 (VAI Wed Sep 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 907153 (VAI Thu Sep 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854744 (VAI Tue Jul 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources