EDWARDS LIFESCIENCES RESPONDS TO FDA WARNING LETTER

Cardiac devicemaker Edwards Lifesciences has responded to an FDA warning letter regarding concerns with the company's quality systems.

Edwards manufactures several cardiac products including heart valves and stent technologies.

During inspections that ended in August 2006, agency investigators had questions about the company's quality systems, including its complaint-handling system, documentation and quality systems training, Edwards said.

The company will not receive premarket approvals for devices "reasonably related" to the good manufacturing practice violations until the issues are resolved, Edwards said.

However, the company added that the violations would not change its 2007 financial forecast.

( http://www.fdanews.com/ddl/34_10/ )