Company
United StatesGE Medical Systems, LLC, Waukesha, WI – FDA Inspections
Inspection records and compliance data for GE Medical Systems, LLC in Waukesha, Wisconsin. 3 FDA inspections on record, last inspected October 11, 2012.
Company Profile
This profile covers GE Medical Systems, LLC based in Waukesha, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 11, 2011. Last inspected October 11, 2012.
Most cited issue areas
- Procedures not adequately established or maintained2 inspections
- Class II "Caution" label1 inspection
- Failure to submit, distinct marking1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 11, 2012 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 803966 |
| March 2, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 769374 |
| January 11, 2011 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 705630 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
GE Medical Systems, LLC
FEI Number
2183553
Address
3200 N Grandview Blvd, Waukesha, Wisconsin 53188, United States
Country
United States
ID: 7ecbf4c0-67eb-4a30-96b8-a15e2b8cfeab