Life-Tech, Inc. - March 4, 2009`
Issue Date
Mar 04, 2009
Region
Southwest
Category
Device
$117.00
Address 1
13235 N. Promenade Blvd.
City
Stafford
State
TX
Zip/Postal Code
77477-1918
Country
US
Inspection Range
Feb 24, 2009 - Mar 04, 2009
Pages
8
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): Jocelyn C. Turner