FDA Warning Letter For Edwards Lifesciences Over Quality Systems Compliance

Such are the wonders of the US financial disclosure rules, Edwards Lifesciences Corporation is compelled to tell us it has received a warning letter from the U.S. FDA resulting from an inspection of Edwards’ facility in Draper, Utah.


The FDA warning, coming after a February inspection, relates specifically to the execution of the company’s quality systems within the Cardiac Surgery Systems (CSS) business, including design and process validation, corrective and preventive actions, finished device acceptance and packaging. The company does not expect this matter to have a material impact on its 2013 financial guidance.

Edwards’ Utah facility manufactures devices for CSS, such as cannulae and cardioplegia catheters, and also makes devices for other Edwards businesses, including heart valve repair rings and transcatheter heart valve delivery system components and accessories.

The letter states that, until Edwards resolves the issues in the warning letter, it will not receive premarket approvals for devices reasonably related to those issues.

Company comments

“We are committed to thoroughly addressing the issues identified with the quality systems for our CSS devices, and have already initiated responses to address FDA’s observations,” said Michael A. Mussallem, Edwards’ chairman and CEO. “Our first priority is delivering quality, life-saving devices to patients.”

Source: Edwards Lifesciences Corporation