FDA Inspection
GE Hangwei Medical Systems, Co. LTDGE Hangwei Medical Systems, Co. LTD – FDA Inspection, Sep 1, 2011
Record Details
This FDA Inspection record concerns GE Hangwei Medical Systems, Co. LTD, with an inspection on September 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 1, 2011
- Product Type
- Devices
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ID · e17c1c4a-cbbd-4917-b8d4-4c8676fcf9cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749189
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(d)Evaluation, timeliness, identification
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Other FDA inspections of GE Hangwei Medical Systems, Co. LTD
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2018 | Not classified | Office of Inspections and Investigations | |
| December 12, 2017 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 22, 2017 | Not classified | Office of Inspections and Investigations | |
| September 22, 2017 | Not classified | Office of Inspections and Investigations | |
| July 30, 2015 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for GE Hangwei Medical Systems, Co. LTD
- FDA Inspection 1132247 - 2018-09-14
- FDA Inspection 1038962 - 2017-12-12
- FDA Inspection 1060550 - 2017-09-22
- FDA Inspection 1051347 - 2017-09-22
- FDA Inspection 936991 - 2015-07-30
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