GE Healthcare Inc., Arlington Heights, IL – FDA Inspections

Inspection records and compliance data for GE Healthcare Inc. in Arlington Heights, Illinois. 10 FDA inspections on record, last inspected September 19, 2025.

Company Profile

This profile covers GE Healthcare Inc. based in Arlington Heights, Illinois, United States.

FDA Inspection History

FDA inspections: 10
OAI: 0
VAI: 2
NAI: 7
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected July 2, 2009. Last inspected September 19, 2025.

Most cited issue areas

Complete test data included in records1 inspection
Control procedures to monitor and validate performance1 inspection
Ensuring compliance with plan and protocol1 inspection

FDA inspections (10)

Date	Result	FDA center(s)	Insp. #
September 19, 2025	NAI	Human Drugs · Drug Quality Assurance	1287530
March 8, 2024	VAI	Human Drugs · Bioresearch Monitoring	1232232
October 2, 2023	Not classified	Human Drugs	1221712
January 24, 2020	NAI	Human Drugs · Drug Quality Assurance	1117219
September 6, 2017	NAI	Medical Devices & Rad Health · Compliance: Devices	1026911
March 5, 2015	NAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	916324
July 9, 2013	NAI	Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance	838003
February 13, 2012	NAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	766454
April 8, 2010	VAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	657027
July 2, 2009	NAI	Human Drugs · Drug Quality Assurance	595065

FDA documents

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

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