FDA 483 - Monica Bhatia, MD - January 31, 2019

This FDA Form 483 was issued to Monica Bhatia, MD, a clinical investigator in New York, NY, following an inspection from January 28-31, 2019. The inspection revealed significant issues related to the conduct of clinical research, specifically concerning the timely reporting of study changes to the IRB and adherence to the investigational plan. These findings indicate a lack of adequate oversight and compliance with regulatory requirements for clinical trials, including proper dosing and timely reporting of serious adverse events.