Investigator Cited for Failure to Report Patient Death

A clinical investigator in a device trial failed to report a patient’s death to the sponsor for almost two years, according to a July 20 FDA warning letter. Robert Phillips of Florence, S.C., told the FDA the tardy report was an oversight that he has corrected, but the agency says his response is inadequate because he did not provide corrective or preventive actions to ensure that the violation does not recur.
Device and Diagnostics Letter