Home / Import refusals / 799-9691005-7/10003/1

FDA Import Refusal 799-9691005-7/10003/1 — Amgen Manufacturing Limited LLC

Amgen Manufacturing Limited LLC — FEI 1000110364

The FDA refused shipment 799-9691005-7/10003/1 from Amgen Manufacturing Limited LLC (United States) on December 9, 2025. The refused product falls under Drugs and Biologics — ROMOSOZUMAB-AQQG. Cited charge: 75 This firm has 2 other import refusals on record.

Refusal Details

Date
December 9, 2025
Country
United States
Product Category
Drugs and Biologics
Product Code
58OCK12 ROMOSOZUMAB-AQQG
Charges
75

Recent inspections

  • 1294400 (VAI Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1209484 (VAI Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1085900 (VAI Thu Apr 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061201 (VAI Mon Aug 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016325 (VAI Wed May 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • NUV-3849644-7/10002/1 (Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-2944699-3/21/1 (Tue Aug 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources