Home / Import refusals / NUV-3849356-8/20002/1

FDA Import Refusal NUV-3849356-8/20002/1 — Regeneron Pharmaceuticals Inc

Regeneron Pharmaceuticals Inc — FEI 1000514603

The FDA refused shipment NUV-3849356-8/20002/1 from Regeneron Pharmaceuticals Inc (United States) on November 3, 2025. The refused product falls under Drugs and Biologics — DUPILUMAB. Cited charge: 179 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 3, 2025
Country
United States
Product Category
Drugs and Biologics
Product Code
58ACP02 DUPILUMAB
Charges
179

Recent inspections

  • 1230565 (VAI Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155063 (VAI Mon Oct 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106821 (VAI Fri Oct 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030807 (NAI Thu Oct 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983604 (VAI Fri Aug 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-7474730-2/10001/1 (Wed Sep 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-2427398-1/11/1 (Tue Feb 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • UPS-7482912-9/11/1 (Tue Mar 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • UPS-7590868-2/11/1 (Mon Feb 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0930297-5/21/1 (Tue Jun 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources