Cardiac Science Inspection Leads to Six Form 483 Observations

Design output and corrective and preventive action (CAPA) failures are among six observations in a Form 483 to Cardiac Science. The Bothell, Wash., facility did not document CAPA activities, including investigations of nonconformities, according to the form. The company had no documentation to show a failure investigation was initiated after an automated external defibrillator failed to shock during a demonstration, despite previous similar complaints.
The GMP Letter