Company
ChinaGE 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.
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)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 8, 2026 | Not classified | Medical Devices & Rad Health | 1300982 |
| July 5, 2018 | Not classified | Medical Devices & Rad Health | 1061400 |
| February 5, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 913085 |
| February 16, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 771719 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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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