Issued: 7/20/11
Region: Southeast
Category: Device 483s
Inspection date range: 7/5/11-7/20/11
Pages: 6
Company: Heartware, Inc.
14000 NW 57th Ct.
Miami Lakes, FL 33014-3105
Inspector(s): Dawn M. McCabe
Observations: Procedures for corrective and preventive action have not been adequately established.
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