Home / Import refusals / AEK-0411006-7/2/3

AEK-0411006-7/2/3

ICU Medical, Inc. — FEI 3013319212

Recent inspections

  • 1250066 (NAI Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984996 (NAI Thu Jul 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925591 (OAI Wed May 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923940 (NAI Tue Apr 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 881787 (NAI Wed May 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-8242634-5/11/1 (Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • EI5-5506310-3/21/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EI5-5506310-3/21/2 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EI5-5506310-3/31/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EI5-5506310-3/11/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

Refusal Details

Date
November 13, 2014
Country
United States
Product Category
Drugs and Biologics
Product Code
62OCB24 DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II)
Charges
75