Home / Import refusals / F23-9340393-6/50002/1

FDA Import Refusal F23-9340393-6/50002/1 — Amgen Europe BV

Amgen Europe BV — FEI 3005889661

The FDA refused shipment F23-9340393-6/50002/1 from Amgen Europe BV (Netherlands) on September 3, 2025. The refused product falls under Drugs and Biologics — DENOSUMAB. Cited charge: 75 This firm has 1 other import refusal on record.

Refusal Details

Date
September 3, 2025
Country
Netherlands
Product Category
Drugs and Biologics
Product Code
58MCY21 DENOSUMAB
Charges
75

Recent inspections

  • 1204167 (VAI Tue May 03 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1041358 (NAI Thu Jan 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • SCS-0846626-2/11/1 (Thu Jul 02 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources