Home / Import refusals / AEK-9378844-4/10002/1

FDA Import Refusal AEK-9378844-4/10002/1 — Sanofi Winthrop Industrie

Sanofi Winthrop Industrie — FEI 1000610805

The FDA refused shipment AEK-9378844-4/10002/1 from Sanofi Winthrop Industrie (France) on February 19, 2026. The refused product falls under Drugs and Biologics — ENOXAPARIN SODIUM (ANTI-COAGULANT). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
February 19, 2026
Country
France
Product Category
Drugs and Biologics
Product Code
61LCK29 ENOXAPARIN SODIUM (ANTI-COAGULANT)
Charges
75

Recent inspections

  • 1181600 (VAI Fri Dec 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992633 (VAI Mon Oct 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904598 (NAI Fri Nov 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812463 (VAI Tue Sep 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 705370 (VAI Fri Dec 10 2010 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-9124494-5/20002/1 (Wed Dec 17 2025 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