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Irvine-based heart valve maker Edwards Lifesciences Corp. said today that it received a warning letter from the Food and Drug Administration concerning its Draper, Utah plant.
Edwards said the FDA’s warning related to the execution of quality systems in its cardiac surgery systems business, including design and process validation and packaging.
The Draper plant manufactures catheters and various other devices, such as heart valve repair rings and transcatheter heart valve delivery system components and accessories.
Edwards executives 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,” Chief Executive Michael Mussallem said.
Regulators said that until Edwards resolves the quality matters, it won’t receive premarket approvals for devices “reasonably related to those issues.”
Edwards released news of the FDA warning after the market closed today. Shares closed down 2% to a market value of $7.25 billion.