FDA Inspection
GE Medical Systems, LLCGE Medical Systems, LLC – FDA Inspection, Jan 11, 2011
Record Details
This FDA Inspection record concerns GE Medical Systems, LLC, with an inspection on January 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GE Medical Systems, LLC
- Inspection Date
- January 11, 2011
- Product Type
- Devices
View Company Profile
ID · da47f672-c0cd-4353-82ed-69dc0d71fd4c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 705630
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 1040.10(g)(1)(ii)Class II "Caution" label
- 21 CFR 1002.10Failure to submit, distinct marking
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GE Medical Systems, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 11, 2012 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 2, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for GE Medical Systems, LLC
- FDA Inspection 803966 - 2012-10-11
- FDA Inspection 769374 - 2012-03-02
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