Insight Instruments, Inc. - 2/17/2012
Issue Date
Feb 17, 2012
Region
Southeast
Category
Device
$117.00
Address 1
2580 Se Willoughby Blvd
City
Stuart
State
FL
Zip/Postal Code
34994
Country
United States
Inspection Range
Feb 13, 2012 - Feb 17, 2012
Pages
4
First Observation
The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.
Investigator(s): Joshua J. Silvestri