Company
United StatesGE Healthcare - Repair Operations Center, Oak Creek, WI – FDA Inspections
Inspection records and compliance data for GE Healthcare - Repair Operations Center in Oak Creek, Wisconsin. 2 FDA inspections on record, 1 Form 483, last inspected July 18, 2023.
Company Profile
This profile covers GE Healthcare - Repair Operations Center based in Oak Creek, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 1, 2019. Last inspected July 18, 2023.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 18, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1210335 |
| February 1, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1083962 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
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Company Information
Name
GE Healthcare - Repair Operations Center
FEI Number
3013679558
Address
120 W Opus Dr Unit B, Oak Creek, Wisconsin 53154, United States
Country
United States
ID: 6dfc8328-5989-46d0-a0dc-ab31cb73ea5f