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Import refusals
/ 112-2441278-8/1/56
112-2441278-8/1/56
ICU Medical, Inc. — FEI 3013319212
Recent inspections
1250066
(NAI Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
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(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))
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881787
(NAI Wed May 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (394420)
(Thu May 09 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (99787)
(Mon Apr 12 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
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
September 11, 2012
Country
United States
Product Category
Drugs and Biologics
Product Code
61XCK18 DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC)
Charges
179