Cardiac Science, Inc., a leading manufacturer of life-saving automated public-access defibrillators (AED) and provider of comprehensive AED/CPR training services, said today that it received a Warning Letter following a routine inspection of its manufacturing facility in Minneapolis conducted by the U.S. Food and Drug Administration (FDA) from January 13 to 28 of this year.
The letter, which was dated March 29, 2004, specified certain procedural and documentation items in the Company's quality system that the FDA found not to be in compliance. The Letter did not relate to the usability, safety or efficacy of the Company's AEDs.
Cardiac Science has initiated permanent corrective and preventive action in its quality system to bring each of the items into compliance and it has formally responded to the FDA in writing, documenting all corrective steps taken.
Cardiac Science Senior Vice President of Operations Guy Sohie said that the Company took immediate steps to correct the procedural and documentation issues cited by the FDA and believes it is in full compliance with all FDA quality standards.
Cardiac Science Cardiac Science develops, manufactures and markets Powerheart(R)-brand public-access defibrillators (AEDs) and offers comprehensive AED/CPR training and AED program management services that facilitate successful deployments. The Company also makes the Powerheart(R) CRM(TM), the only FDA-cleared therapeutic patient monitor that instantly and automatically treats hospitalized cardiac patients who suffer life-threatening heart rhythms. Cardiac Science also manufactures its AED products on a private label basis for other leading medical companies. For more information, please visit http://www.cardiacscience.com, email Cardiac Science at [email protected] or call toll free at 1-949-797-3800.