Company
ChinaGE Healthcare Shanghai Co., Ltd., Shanghai, China – FDA Inspections
Inspection records and compliance data for GE Healthcare Shanghai Co., Ltd. in Shanghai. 6 FDA inspections on record, 2 Form 483s, last inspected October 30, 2025.
Company Profile
This profile covers GE Healthcare Shanghai Co., Ltd. based in Shanghai, China.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 17, 2008. Last inspected October 30, 2025.
Most cited issue areas
- Investigations of discrepancies, failures1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 30, 2025 | Not classified | Human Drugs | 1295560 |
| May 10, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1055016 |
| August 12, 2016 | VAI | Human Drugs · Drug Quality Assurance | 984196 |
| November 8, 2013 | VAI | Human Drugs · Drug Quality Assurance | 854504 |
| April 15, 2011 | NAI | Human Drugs · Drug Quality Assurance | 727732 |
| October 17, 2008 | VAI | Human Drugs · Drug Quality Assurance | 547503 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
GE Healthcare Shanghai Co., Ltd.
FEI Number
3005292384
Address
No. 1 Niudun Road, Trade Zone, Shanghai, China
Country
China
ID: be6327f6-f1a1-40b7-8eb6-9955a9760762