GE Hangwei Medical Systems, Co. LTD, Beijing, China – FDA Inspections

Inspection records and compliance data for GE Hangwei Medical Systems, Co. LTD in Beijing. 6 FDA inspections on record, 2 Form 483s, last inspected September 14, 2018.

Company Profile

This profile covers GE Hangwei Medical Systems, Co. LTD based in Beijing, China.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 1
NAI: 2
Unclassified: 3
Form 483s: 2
Warning letters: 0

First inspected September 1, 2011. Last inspected September 14, 2018.

Most cited issue areas

Evaluation, timeliness, identification1 inspection
Individual Report of Malfunction1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
September 14, 2018	Not classified	Medical Devices & Rad Health	1132247
December 12, 2017	NAI	Medical Devices & Rad Health · Radiation Control and Health Safety Act	1038962
September 22, 2017	Not classified	Medical Devices & Rad Health	1060550
September 22, 2017	Not classified	Medical Devices & Rad Health	1051347
July 30, 2015	NAI	Medical Devices & Rad Health · Radiation Control and Health Safety Act	936991
September 1, 2011	VAI	Medical Devices & Rad Health · Compliance: Devices	749189

FDA documents

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

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