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FDA Import Refusal SCS-6353097-1/10003/1 — Sanofi Pasteur Limited

Sanofi Pasteur Limited — FEI 3002888623

The FDA refused shipment SCS-6353097-1/10003/1 from Sanofi Pasteur Limited (Canada) on December 19, 2025. The refused product falls under Drugs and Biologics — DUPILUMAB. Cited charge: 3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 19, 2025
Country
Canada
Product Category
Drugs and Biologics
Product Code
58ACP02 DUPILUMAB
Charges
3280

Recent inspections

  • 1264024 (VAI Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1182359 (VAI Fri Oct 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099275 (VAI Fri May 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851779 (VAI Fri Sep 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 783865 (OAI Wed Apr 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-3612602-7/10002/1 (Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9500733-0/10003/1 (Tue May 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0955774-9/10003/1 (Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-8496389-2/11/1 (Wed Mar 04 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • E7E-1026048-2/4/3 (Mon Aug 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources