GE Medical Systems, LLC, Waukesha, WI – FDA Inspections

Inspection records and compliance data for GE Medical Systems, LLC in Waukesha, Wisconsin. 7 FDA inspections on record, 1 Form 483, last inspected September 29, 2022.

Company Profile

This profile covers GE Medical Systems, LLC based in Waukesha, Wisconsin, United States.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 3
NAI: 4
Form 483s: 1
Warning letters: 0

First inspected January 29, 2010. Last inspected September 29, 2022.

Most cited issue areas

Sponsor device shipment records inadequate1 inspection
Supplier oversight1 inspection

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
September 29, 2022	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1182375
June 14, 2018	VAI	Medical Devices & Rad Health · Radiation Control and Health Safety Act	1056044
November 10, 2014	NAI	Medical Devices & Rad Health · Compliance: Devices	902896
February 28, 2014	VAI	Medical Devices & Rad Health · Bioresearch Monitoring	847720
June 17, 2013	VAI	Medical Devices & Rad Health · Compliance: Devices	836285
April 26, 2010	NAI	Medical Devices & Rad Health · Compliance: Devices	659341
January 29, 2010	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	648026

FDA documents

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

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