Company
United StatesGE Medical Systems Information Technologies, Inc., Milwaukee, WI – FDA Inspections
Inspection records and compliance data for GE Medical Systems Information Technologies, Inc. in Milwaukee, Wisconsin. 4 FDA inspections on record, 1 Form 483, last inspected July 19, 2018.
Company Profile
This profile covers GE Medical Systems Information Technologies, Inc. based in Milwaukee, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 20, 2010. Last inspected July 19, 2018.
Most cited issue areas
- Design verification - output does not meet input requirement2 inspections
- Lack of or inadequate procedures2 inspections
- Complaints1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 19, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1059359 |
| September 25, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 849871 |
| October 9, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 802525 |
| August 20, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 679075 |
FDA documents
Form 483s (1)
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Company Information
Name
GE Medical Systems Information Technologies, Inc.
FEI Number
2124823
Address
8200 W Tower Ave, Milwaukee, Wisconsin 53223, United States
Country
United States
ID: 586be979-9267-4943-ab94-6fdae6fafc2d