DMX-Works Imaging, Inc. - June 5, 2015
Issue Date
Jun 09, 2015
Region
Southeast
Category
Device
$117.00
Contact Name
John R. Postlethwaite
Contact Title
President & Owner
Address 1
4159 Corporate Ct.
Address 2
Ste. B
City
Palm Harbor
State
FL
Zip/Postal Code
34683- 1480
Country
United States
Inspection Range
Jun 01, 2015 - Jun 05, 2015
Pages
5
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): Delkis J. Caycedo and Joshua J. Silvestri