Company
JapanGE Healthcare Japan Corporation, Hino, Japan – FDA Inspections
Inspection records and compliance data for GE Healthcare Japan Corporation in Hino. 4 FDA inspections on record, 1 Form 483, last inspected December 15, 2017.
Company Profile
This profile covers GE Healthcare Japan Corporation based in Hino, Japan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 5, 2012. Last inspected December 15, 2017.
Most cited issue areas
- DHR content1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 15, 2017 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1038779 |
| September 15, 2017 | Not classified | Medical Devices & Rad Health | 1081180 |
| May 21, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 932420 |
| April 5, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 781576 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GE Healthcare Japan Corporation
FEI Number
3002808529
Address
Ge Herusukea.Japan ( Kabu -4 Chome 7-127, Asahigaoka, Hino, Japan
Country
Japan
ID: e31a9ca8-9076-4985-88aa-74b0f7c37ddc