Company
United StatesGE OEC Medical Systems, Inc, Salt Lake City, UT – FDA Inspections
Inspection records and compliance data for GE OEC Medical Systems, Inc in Salt Lake City, Utah. 6 FDA inspections on record (1 OAI), 1 Form 483, last inspected August 17, 2023.
Company Profile
This profile covers GE OEC Medical Systems, Inc based in Salt Lake City, Utah, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected November 21, 2008. Last inspected August 17, 2023.
Most cited issue areas
- CAPA verification/validation of corrective/preventive action1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Identification of actions needed1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 17, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1217708 |
| June 29, 2021 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1145789 |
| June 22, 2018 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1056985 |
| March 25, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 920992 |
| September 28, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 747277 |
| November 21, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 550334 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GE OEC Medical Systems, Inc
FEI Number
1720753
Address
384 N Wright Brothers Dr, Salt Lake City, Utah 84116, United States
Country
United States
ID: c9e53b25-aec9-4c7c-89c4-010225a2db6b