HeartWare Int'l. Receives FDA Warning Letter - Quick Facts

(RTTNews) - On June 3, 2014, HeartWare International Inc. (HTWR) received a warning letter from the U.S. Food and Drug Administration or FDA resulting from an inspection of the company's operations, development and manufacturing facility in Miami Lakes, Florida, conducted in January 2014.

The FDA letter cites four categories for the company to address: procedures for validating device design, including device labeling; procedures for implementing corrective and preventive action or CAPA; maintaining records on investigations; and validation of computer software used as part of production or quality systems.

The FDA's letter issued does not require any action by physicians or patients and does not restrict use of HeartWare's devices.

The company takes this matter seriously and would respond to the letter within the required 15 days. 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.