Home / Import refusals / AEK-0481263-1/10001/1

FDA Import Refusal AEK-0481263-1/10001/1 — Amgen, Inc.

Amgen, Inc. — FEI 2026154

The FDA refused shipment AEK-0481263-1/10001/1 from Amgen, Inc. (United States) on July 2, 2026. The refused product falls under Drugs and Biologics — DENOSUMAB. Cited charges: 9999982,9999987 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 2, 2026
Country
United States
Product Category
Drugs and Biologics
Product Code
58MCK21 DENOSUMAB
Charges
9999982,9999987

Recent inspections

  • 1278976 (NAI Thu Aug 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1256132 (VAI Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1220409 (NAI Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1112791 (VAI Fri Dec 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028320 (NAI Mon Aug 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-0699451-0/10001/1 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5144009-1/10001/1 (Sun Jan 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0156013-9/10001/1 (Wed Dec 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8369165-2/10001/1 (Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • NUV-3855286-8/40002/1 (Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources