Home / Import refusals / 799-7622704-2/22/1

FDA Import Refusal 799-7622704-2/22/1 — Amgen, Inc.

Amgen, Inc. — FEI 2026154

The FDA refused shipment 799-7622704-2/22/1 from Amgen, Inc. (United States) on June 3, 2025. The refused product falls under Drugs and Biologics — PARICALCITOL (BONE CALCIUM REGULATOR). Cited charges: 472,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 3, 2025
Country
United States
Product Category
Drugs and Biologics
Product Code
63ADL05 PARICALCITOL (BONE CALCIUM REGULATOR)
Charges
472,75

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-0481263-1/10001/1 (Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 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)

FDA data resources