FDA issues a warning letter to HeartWare International

The US Food and Drug Administration has issued a warning letter to HeartWare International Inc. resulting from an inspection of the company's operations, development and manufacturing facility in Miami Lakes, Florida, conducted in January 2014.

HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure. The HeartWare(R) Ventricular Assist System features the HVAD(R) pump, a small full-support circulatory assist device designed to be implanted next to the heart.

The FDA letter mentioned four categories for the company to address: procedures for validating device design, including device labeling; procedures for implementing corrective and preventive action (CAPA); maintaining records related to investigations; and validation of computer software used as part of production or quality systems. The FDA’s warning letter does not require any action by physicians or patients and does not restrict use of HeartWare's devices.

The company’s spokesperson said that the company is committed to providing the highest quality products in compliance with FDA regulations to ensure the safety and welfare of patients who rely on HeartWare’s devices, and the company is dedicating the resources necessary to address the items discussed in the letter. The firm hopes to implement new and enhanced systems and procedures, and would perform additional actions as may be required to resolve the issues raised in the FDA communication.