FDA Inspection 920992 — GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc — FEI 1720753

The FDA completed an inspection of GE OEC Medical Systems, Inc on March 25, 2015 in Salt Lake City, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 25, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Salt Lake City, UT (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures