FDA 483 - Michele Nanna, M.D. - March 25, 2021

This FDA Form 483 was issued to Michele Nanna, M.D., a clinical investigator in Bronx, NY, following an inspection from March 22-25, 2021. The inspection revealed two significant observations related to the conduct of clinical investigations. Issues included a failure to adhere to the investigational plan and protocol inclusion criteria for a subject, as well as inadequate investigational drug disposition records with inconsistencies in tracking and documentation.