FDA Inspection
GE Medical Systems, LLCGE Medical Systems, LLC – FDA Inspection, Jun 17, 2013
Record Details
This FDA Inspection record concerns GE Medical Systems, LLC, with an inspection on June 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GE Medical Systems, LLC
- Inspection Date
- June 17, 2013
- Product Type
- Devices
View Company Profile
ID · db1c44bb-95b9-49c1-a2e3-d60e95a4a546
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 836285
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.50(a)(2)Supplier oversight
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 |
| February 28, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| 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 847720 - 2014-02-28
- FDA Inspection 659341 - 2010-04-26
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