Genetic Testing Institute, Inc. - January 13, 2010
Issue Date
Jan 13, 2010
Region
Central
Category
Device
$117.00
Address 1
20925 Crossroads Circle
Address 2
Suite 200
City
Waukesha
State
WI
Zip/Postal Code
53186-4054
Country
US
Inspection Range
Jan 04, 2010 - Jan 13, 2010
Pages
3
First Observation
Procedures for planning and conducting reviews of the design results at appropriate stages of the device's design development were not implemented.
Investigator(s): Michelle J. Glembin