FDA Inspection
GE Medical Systems, LLCGE Medical Systems, LLC – FDA Inspection, Feb 28, 2014
Record Details
This FDA Inspection record concerns GE Medical Systems, LLC, with an inspection on February 28, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GE Medical Systems, LLC
- Inspection Date
- February 28, 2014
- Product Type
- Devices
View Company Profile
ID · a4227425-51e3-4560-9877-95a5052b307f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 847720
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.140(b)(2)Sponsor device shipment records inadequate
Full citation text and observation details available on the Dashboard.
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 |
| June 14, 2018 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| November 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 1056044 - 2018-06-14
- FDA Inspection 902896 - 2014-11-10
- FDA Inspection 836285 - 2013-06-17
- FDA Inspection 659341 - 2010-04-26
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