Home / Import refusals / SCS-0238564-1/11/2

FDA Import Refusal SCS-0238564-1/11/2 — Sanofi Winthrop Industrie

Sanofi Winthrop Industrie — FEI 3003282644

The FDA refused shipment SCS-0238564-1/11/2 from Sanofi Winthrop Industrie (France) on April 28, 2020. The refused product falls under Drugs and Biologics — ZOLPIDEM TARTRATE (SEDATIVE). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 28, 2020
Country
France
Product Category
Drugs and Biologics
Product Code
65VCY56 ZOLPIDEM TARTRATE (SEDATIVE)
Charges
75

Recent inspections

  • 1265031 (VAI Fri Jan 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1124660 (VAI Thu Oct 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055737 (VAI Fri Jun 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 881164 (NAI Fri Jun 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 783996 (NAI Fri Mar 23 2012 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