FDA warns heart pump maker with Miami Lakes connection



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.

Read more Miami-Dade stories from the Miami Herald

Miami Herald

Join the

The Miami Herald is pleased to provide this opportunity to share information, experiences and observations about what's in the news. Some of the comments may be reprinted elsewhere on the site or in the newspaper. We encourage lively, open debate on the issues of the day, and ask that you refrain from profanity, hate speech, personal comments and remarks that are off point. Thank you for taking the time to offer your thoughts.

The Miami Herald uses Facebook's commenting system. You need to log in with a Facebook account in order to comment. If you have questions about commenting with your Facebook account, click here.

Have a news tip? You can send it anonymously. Click here to send us your tip - or - consider joining the Public Insight Network and become a source for The Miami Herald and el Nuevo Herald.

Hide Comments

This affects comments on all stories.

Cancel OK

  • Marketplace

Today's Circulars

  • Quick Job Search

Enter Keyword(s) Enter City Select a State Select a Category