The FDA sends HeartWare International (HTWR) a warning letter after it conducted an on-site inspection of the company's Miami Lakes manufacturing facility in January. The notification cites four deficiencies the company needs to address: procedures for validating device design, including labeling; procedures for implementing corrective and preventive action; maintaining records related to investigations; validation of computer software used in production or quality systems.
The letter does not require any action by physicians or patients. HTWR will respond to the FDA within the required 15 days.
President & CEO Doug Godshall says, "HeartWare is committed to providing the highest quality products in compliance with FDA regulations to ensure the safety and welfare of patients who rely on our devices and we are dedicating the resources necessary to address the items discussed in the letter."