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FDA Import Refusal F23-9339758-3/120002/1 — Genzyme Ireland Limited

Genzyme Ireland Limited — FEI 3003809840

The FDA refused shipment F23-9339758-3/120002/1 from Genzyme Ireland Limited (Ireland) on September 3, 2025. The refused product falls under Drugs and Biologics — DUPILUMAB. Cited charge: 75 This firm has 2 other import refusals on record.

Refusal Details

Date
September 3, 2025
Country
Ireland
Product Category
Drugs and Biologics
Product Code
58ACY02 DUPILUMAB
Charges
75

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))

Compliance actions

Other import refusals

  • 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