FDA 483 - D'Alessandro, Anthony M. - June 18, 2021

An FDA inspection of Dr. Anthony M. D'Alessandro, a clinical investigator in Madison, WI, revealed significant deficiencies in the conduct of the OrganOx WP01 clinical research study. The firm failed to maintain accurate, complete, and current subject case histories and source documents, and did not properly manage or report protocol deviations. Additionally, the investigational device was not maintained according to the agreed-upon plan, leading to its use past its maintenance due date.