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 similar previous complaints.
Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified, the form adds.
A Sept. 1 to Oct. 1 inspection also revealed the company’s design verification lacked documented testing to verify batteries have adequate capacity for 300 shocks and a three-year operating life under normal conditions.
Cardiac Science is working closely with the FDA to address the observations and resolve any issues, company spokesman Joe Hage told FDAnews.
The Form 483 is available at www.fdanews.com/ext/files/1170_001.pdf. — April Hollis
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