An FDA warning letter to Edwards Lifesciences Corp. alleges problems with the manufacturing quality systems at its Draper, Utah, facility that makes components for the Sapien transcatheter aortic valve delivery system, according to a May 29 statement from the company. The warning followed an FDA inspection of the plant that concluded in February, and cites issues related to design and process validation, corrective and preventive action, and finished device acceptance and packaging, the firm said. The company also makes cannulae and cardioplegia catheters associated with its cardiac surgery systems business and heart valve repair rings.
Edwards does not expect the matter to affect its 2013 financial guidance, nor delay FDA approval of its second-generation Sapien XT transcatheter aortic valve, now under review at the agency...
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