FDA Warns HeartWare for Validation, CAPA Concerns

Coronary devicemaker HeartWare International has received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility.

The June 3 letter, which followed a January FDA inspection, cites the plant for deviations related to validating device design, including device labeling, corrective and preventive action implementation procedures, maintaining records on investigations and validating computer software used in production and quality systems.

HeartWare said it would respond within the 15-day timeframe requested by the FDA, and would implement new and enhanced systems and procedures and take any additional steps required to settle the agency’s concerns.

“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 HeartWare CEO Doug Godshall.

Leerink Partners analyst Danielle Antalffy called the warning letter “as benign as possible within the context of [warning letters],” because it won’t take HeartWare’s ventricular assist device off the market or halt ongoing clinical trial enrollments.

This is the second setback for HeartWare in the last several months. In April, the company recalled batteries used in the HeartWare VAD due to premature depletion. There is no apparent connection between the recall and the warning letter, which has not yet been made public.

CAPA programs remain the top issue triggering warning letters. Learn what steps to take to satisfy the FDA with Principles of an Effective CAPA System: A Guide for Device and Drug Companies.