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Genzyme Ireland Limited — FDA Facility Profile

FEI 3003809840

Genzyme Ireland Limited is an FDA-registered facility (FEI 3003809840) located in X91 TP27, IE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK; STERILIZE. RegDataLab tracks 9 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
X91 TP27 (IE)
Registration Expires
December 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK; STERILIZE
Source
decrs

Recent inspections

  • 1174738 (VAI Fri Feb 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 751377 (VAI Fri Sep 30 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 638081 (VAI Fri Oct 30 2009 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 554262 (NAI Thu Nov 20 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • F23-9339758-3/120002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7529870-9/1/1 (Wed Nov 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-3794094-1/2/1 (Tue Jul 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources