Edwards Lifesciences gets FDA warning letter
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Edwards Lifesciences Corp., a maker of artificial heart valves, received a warning letter about quality control at its Irvine plant from the Food and Drug Administration.
The warning came after U.S. inspectors found problems with quality systems, documentation and complaint handling, the company said.
Until Edwards resolves problems identified in the letter, it won’t receive pre-market approvals for any devices “reasonably related to those issues,” the company said.
Edwards shares fell $1.43 to $50.98.
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