Home » Cardiac Science Inspection Leads to Six Form 483 Observations
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
The GMP Letter
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