FDA 483 - Heartware, Inc. - May 04, 2016

HeartWare, Inc. in Miami Lakes, FL, a medical device manufacturer, was cited for significant deficiencies across its quality system. The inspection revealed inadequate procedures for MDR reporting, corrective and preventive actions, complaint handling, process validation, design transfer, servicing verification, and supplier management. These issues indicate a systemic failure to ensure product quality, safety, and regulatory compliance for their vascular assisted devices.