The U.S. Food and Drug Administration (FDA) issued a warning letter March 1 to Edwards Lifesciences Inc., saying that the firm failed to report six complaints to the agency that resulted in death or serious injury. This decision comes after a September inspection in Irvine, Calif., by the agency.
In addition, the FDA said Edwards’ annuloplasty ring devices and pericardial heart valve devices are misbranded since the firm did not furnish information about the device required in Medical Device Reporting regulation.
The FDA said in the warning letter that Edwards should take “prompt action to correct the violation in this letter. Failure to promptly correct this violation may result in regulatory action being initiated by the Food and Drug Administration without further notice.”
Edwards Lifesciences said in a statement: "The company’s training procedures on the MDR reporting process were corrected during the inspection and discussed with the FDA. The FDA subsequently issued its Establishment Inspection Report in October 2009 concluding its inspection."
Edwards does not expect this matter to have any impact on product approvals.
To see the complete warning letter, click here.