FDA Inspection
GE Healthcare Japan CorporationGE Healthcare Japan Corporation – FDA Inspection, Apr 5, 2012
Record Details
This FDA Inspection record concerns GE Healthcare Japan Corporation, with an inspection on April 5, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 5, 2012
- Product Type
- Devices
View Company Profile
ID · fa0222d7-7f2f-4800-9b54-25f9ce7ea3ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781576
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GE Healthcare Japan Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2017 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 15, 2017 | Not classified | Office of Inspections and Investigations | |
| May 21, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for GE Healthcare Japan Corporation
- FDA Inspection 1038779 - 2017-12-15
- FDA Inspection 1081180 - 2017-09-15
- FDA Inspection 932420 - 2015-05-21
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