FDA Inspection 812255 — Q.I. Medical, Inc.

Q.I. Medical, Inc. — FEI 1000123689

The FDA completed an inspection of Q.I. Medical, Inc. on December 18, 2012 in Grass Valley, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 18, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Grass Valley, CA (United States)

Citations

IDCFRDescription
319221 CFR 820.30(g)Design validation - user needs and intended uses