ICU Medical, Inc. (NASDAQ: ICUI), Lake Forest, IL – FDA Inspections

Inspection records and compliance data for ICU Medical, Inc. in Lake Forest, Illinois. 9 FDA inspections on record (2 OAI), last inspected September 09, 2024. Publicly traded as NASDAQ: ICUI.

Company Profile

This profile covers ICU Medical, Inc. based in Lake Forest, Illinois, United States.

FDA Inspection History

FDA inspections: 9
OAI: 2
VAI: 1
NAI: 5
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected July 20, 2009. Last inspected September 9, 2024.

Most cited issue areas

Lack of or inadequate procedures3 inspections
Design changes - Lack of or Inadequate Procedures2 inspections
Evaluation of suppliers, contractors, etc., requirements2 inspections

FDA inspections (9)

Date	Result	FDA center(s)	Insp. #
September 9, 2024	NAI	Human Drugs · Bioresearch Monitoring	1250066
March 17, 2017	Not classified	Medical Devices & Rad Health	1018654
July 14, 2016	NAI	Medical Devices & Rad Health · Compliance: Devices	984996
May 27, 2015	OAI	Medical Devices & Rad Health · Compliance: Devices	925591
April 21, 2015	NAI	Human Drugs · Bioresearch Monitoring	923940
May 28, 2014	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	881787
February 7, 2013	OAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	818394
July 13, 2012	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	793071
July 20, 2009	NAI	Medical Devices & Rad Health · Compliance: Devices	603887

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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