FDA 483 - David L. Wirta, M.D. - August 13, 2021

David L. Wirta, M.D., a clinical investigator in Newport Beach, CA, was cited for failing to maintain adequate and accurate case histories during a human clinical study of an investigational drug. The firm did not report investigational drugs taken as concomitant medications in electronic case report forms for subjects enrolled in multiple studies. This issue impacts the integrity and accuracy of the clinical trial data.