FDA 483 - John O Mascarenhas, M.D. - July 01, 2021

An FDA inspection of John O Mascarenhas, M.D., a clinical investigator in New York, NY, identified two observations. The inspection found failures in maintaining adequate and accurate case histories, specifically regarding the reporting of adverse events and concomitant medications in the eCRF. Additionally, investigational records were not retained for the required period following drug marketing application approval.