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ICU MEDICAL, INC. — FDA Facility Profile

FEI 3013319212

ICU MEDICAL, INC. is an FDA-registered facility (FEI 3013319212) located in Lake Forest, IL, US. RegDataLab tracks 8 FDA inspections and 3 compliance actions at this facility.

Facility Details

Location
Lake Forest, IL (US)
Registration Expires
N/A
Operations
Source
device

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 (VAI Wed May 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 818394 (OAI Thu Feb 07 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793071 (VAI Fri Jul 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 603887 (NAI Mon Jul 20 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • BUP-1603204-0/5/1 (Thu Oct 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0411006-7/2/3 (Thu Nov 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0289424-0/2/7 (Tue Nov 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0289424-0/2/1 (Tue Nov 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-2441278-8/1/59 (Fri Nov 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-2441278-8/1/61 (Tue Sep 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-2441278-8/1/63 (Tue Sep 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-2441278-8/1/56 (Tue Sep 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-2441278-8/1/57 (Tue Sep 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-2441278-8/1/1 (Tue Sep 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources