FDA issues warning to HeartWare
HeartWare International Inc. of Framingham said it received a warning letter following an inspection by the U.S. Food and Drug Administration (FDA) at its developing and manufacturing facility in Miami Lakes, Fla.
The letter cites four categories for the company to address, but it does not restrict use of HeartWare devices or require any action by doctors or patients, according to a statement from the company.
HeartWare, which makes devices that treat patients suffering from advanced heart failure, is ordered to address: procedures for validating device design, including labeling; procedures for implementing corrective and preventive action; maintaining records related to investigations, and validation of computer software use in production or quality systems.
“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,” said Doug Godshall, president and CEO of HeartWare.
WBJ Web Partners
Most Recent
Most Recent
0 Comments