Home / Import refusals / AEK-8219175-8/11/1

FDA Import Refusal AEK-8219175-8/11/1 — Sanofi-Aventis Deutschland GmbH

Sanofi-Aventis Deutschland GmbH — FEI 3003195501

The FDA refused shipment AEK-8219175-8/11/1 from Sanofi-Aventis Deutschland GmbH (Germany) on March 4, 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
March 4, 2025
Country
Germany
Product Category
Drugs and Biologics
Product Code
58ACY02 DUPILUMAB
Charges
75

Recent inspections

  • 1215824 (VAI Fri Mar 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1094836 (VAI Tue May 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006001 (VAI Fri Mar 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 952968 (NAI Thu Dec 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933399 (VAI Fri Jun 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • NUV-3886004-8/10002/1 (Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0956734-2/10002/1 (Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7861722-0/20002/1 (Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7861722-0/30002/1 (Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-9382463-3/11/1 (Mon Apr 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources