Home / Import refusals / F23-9340161-7/60002/1

FDA Import Refusal F23-9340161-7/60002/1 — Sanofi Winthrop Industrie

Sanofi Winthrop Industrie — FEI 3003259844

The FDA refused shipment F23-9340161-7/60002/1 from Sanofi Winthrop Industrie (France) on September 3, 2025. The refused product falls under Drugs and Biologics — DUPILUMAB. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

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

Recent inspections

  • 1206033 (VAI Tue Apr 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1133485 (VAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981020 (VAI Tue Jul 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925345 (NAI Thu Apr 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872369 (VAI Fri Mar 28 2014 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-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)

FDA data resources