Home / Import refusals / AEK-9124494-5/20002/1

FDA Import Refusal AEK-9124494-5/20002/1 — Sanofi Winthrop Industrie

Sanofi Winthrop Industrie — FEI 3002808208

The FDA refused shipment AEK-9124494-5/20002/1 from Sanofi Winthrop Industrie (France) on December 17, 2025. The refused product falls under Drugs and Biologics — CLOPIDOGREL BISULFATE (ANTI-COAGULANT). Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 17, 2025
Country
France
Product Category
Drugs and Biologics
Product Code
61LCA38 CLOPIDOGREL BISULFATE (ANTI-COAGULANT)
Charges
118

Recent inspections

  • 1267532 (VAI Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1094501 (VAI Fri Apr 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 861974 (VAI Fri Dec 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 753776 (NAI Fri Nov 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 560525 (VAI Fri Jan 23 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-0516922-1/10002/1 (Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0272725-2/10002/2 (Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9378844-4/10002/1 (Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7507384-9/10002/1 (Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • F23-9339962-1/90002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources