FDA warns heart pump maker with Miami Lakes connection

 

astewart@miamiherald.com

A medical device company with a facility in Miami Lakes received a warning from the U.S. Food and Drug Administration.

The warning was based on findings from a January inspection, according to Heartware International, a manufacturer of left ventricle heart assist pumps headquartered in Framingham, Mass.

The FDA listed four categories for Heartware to address: procedures for validating device design, procedures for implementing corrective and preventive action, maintaining records related to investigations and validation of computer software used as part of production or quality systems.

The company plans to implement new systems and procedures in response. A company spokesperson declined to comment.

The FDA will not require any action by doctors or patients and will not restrict use of the heart pumps.

In 2011, the company signed a 10-year lease for more than 130,000 square feet at Miami Lakes Industrial Park, 14560 NW 60th Ave.

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