Home / Import refusals / NUV-3855286-8/30002/1

FDA Import Refusal NUV-3855286-8/30002/1 — Sandoz GmbH

Sandoz GmbH — FEI 3004828473

The FDA refused shipment NUV-3855286-8/30002/1 from Sandoz GmbH (Austria) on November 3, 2025. The refused product falls under Drugs and Biologics — ADALIMUMAB-ADAZ. Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 3, 2025
Country
Austria
Product Category
Drugs and Biologics
Product Code
58SCP02 ADALIMUMAB-ADAZ
Charges
118

Recent inspections

  • 1195376 (VAI Thu Jan 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1205998 (VAI Mon Jul 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981928 (VAI Tue Jul 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872125 (NAI Tue Mar 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773115 (NAI Fri Mar 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 1FX-9378206-7/10002/1 (Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-0551040-8/10002/2 (Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7679334-6/20003/1 (Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7432086-0/30002/1 (Fri Aug 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7717029-0/32/1 (Tue Jun 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources