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GE Medical Systems China Co., Ltd., Wuxi, China – FDA Inspections

Inspection records and compliance data for GE Medical Systems China Co., Ltd. in Wuxi. 4 FDA inspections on record, last inspected January 08, 2026.

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Company Profile

This profile covers GE Medical Systems China Co., Ltd. based in Wuxi, China.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
2
NAI
0
Unclassified
2
Form 483s
0
Warning letters
0

First inspected February 16, 2012. Last inspected January 8, 2026.

Most cited issue areas

  • Investigation of device failures1 inspection
  • Lack of or inadequate complaint procedures1 inspection
  • Lack of or inadequate DHR procedures1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
January 8, 2026Not classifiedMedical Devices & Rad Health1300982
July 5, 2018Not classifiedMedical Devices & Rad Health1061400
February 5, 2015VAIMedical Devices & Rad Health · Compliance: Devices913085
February 16, 2012VAIMedical Devices & Rad Health · Compliance: Devices771719
FDA documents

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

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Shenzhen Pacom Medical Instruments Co., Ltd.
Dongguan Mars Medical Products Co., Ltd.
Changshu Beyond Medical Device Co., Ltd.
Plexus (Xiamen) Co Ltd
Beijing Polycon Medical Engineering Ltd.
Nantong Egens Biotechnology Co., Ltd.
Company Information

Name

GE Medical Systems China Co., Ltd.

FEI Number

3003513129

Address

Dev. Zone, National Hi-Tech; No. 19 Changjiang Road; Xin, Wuxi, China

Country

China

ID: 4592b361-8ce1-4a30-87ed-5681f6eee472

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