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FDA Warns Of Problems At Edwards Lifesciences Corp's Utah Facility-DJ

Wednesday, 29 May 2013 05:09pm EDT 

Dow Jones reported that Edwards Lifesciences Corp said a U.S. Food and Drug Administration inspection has identified a series of problems at the medical-device maker's Utah facility. The FDA issued a warning letter related to the Company's heart-surgery devices, and identified quality control issues tied to design and manufacturing processes and packaging. Edwards' Draper, Utah, facility makes devices like heart catheters, as well as heart valve repair rings and transcatheter heart valve components and accessories. The letter means that the Company won't receive premarket approvals for devices tied to the problems identified by the FDA. Edwards Chief Executive Michael A. Mussallem said the Company has initiated responses to address the FDA observations. 

Company Quote

-0.39 -0.38%
16 Sep 2014