FDA 483 - Adarsh Daswani, M.D. - October 29, 2021

This FDA Form 483 was issued to Adarsh Daswani, M.D., following an inspection that revealed significant deficiencies in the conduct and supervision of a clinical investigation. The inspection found failures in investigator oversight, adherence to the investigational plan, maintenance of accurate case histories, and proper accountability for investigational drug disposition. These issues indicate a lack of control over critical aspects of the clinical trial.