Biolife, LLC - June 28, 2013
Issue Date
Jun 28, 2013
Region
Southeast
Category
Device
$117.00
Contact Name
Stuart W. Jones
Contact Title
President
Address 1
8163 25th Court East
City
Sarasota
State
FL
Zip/Postal Code
34243-2800
Country
United States
Inspection Range
Jun 25, 2013 - Jun 28, 2013
Pages
2
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): Melanie G. Warzala