FDA Inspection
GE Medical Systems, LLCGE Medical Systems, LLC – FDA Inspection, Jun 14, 2018
Record Details
This FDA Inspection record concerns GE Medical Systems, LLC, with an inspection on June 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 93c614db-d0f1-4123-bfbf-945c4c900d66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056044
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
Other FDA inspections of GE Medical Systems, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 28, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 17, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 26, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GE Medical Systems, LLC
- FDA Inspection 1182375 - 2022-09-29
- FDA Inspection 902896 - 2014-11-10
- FDA Inspection 847720 - 2014-02-28
- FDA Inspection 836285 - 2013-06-17
- FDA Inspection 659341 - 2010-04-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.