Heartware, Inc. - July 20, 2011
Issue Date
Jul 20, 2011
Region
Southeast
Category
Device
$117.00
Address 1
14000 NW 57th Ct.
City
Miami Lakes
State
FL
Zip/Postal Code
33014-3105
Country
US
Inspection Range
Jul 05, 2011 - Jul 20, 2011
Pages
6
First Observation
Procedures for corrective and preventive action have not been adequately established.
Investigator(s): Dawn M. McCabe