HeartSine Technologies, Inc Warned By FDA For Medtech Reporting, Tracking Violations

The FDA warns HeartSine Technologies for violations related to adverse event reporting standards and medical device tracking at a Pennsylvania AED manufacturing facility. HeartSine Technologies is in more hot water with the FDA this month after receiving an agency warning letter citing medical device reporting and tracking violations at a Pennsylvania facility. The FDA dinged HeartSine for "failure to adequately develop, maintain and implement written [medical device reporting] procedures" and misbranding of the company's automated external defibrillators.

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