FDA Inspection
GE Medical Systems China Co., Ltd.GE Medical Systems China Co., Ltd. – FDA Inspection, Feb 16, 2012
Record Details
This FDA Inspection record concerns GE Medical Systems China Co., Ltd., with an inspection on February 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 16, 2012
- Product Type
- Devices
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ID · 14259e07-059c-4d72-a509-a0fc6c47e9f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 771719
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.52(a)(1)Patient Name or Other Identifier
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of GE Medical Systems China Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2026 | Not classified | Office of Inspections and Investigations | |
| July 5, 2018 | Not classified | Office of Inspections and Investigations | |
| February 5, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GE Medical Systems China Co., Ltd.
- FDA Inspection 1300982 - 2026-01-08
- FDA Inspection 1061400 - 2018-07-05
- FDA Inspection 913085 - 2015-02-05
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