FDA 483 - Monica M. Mita, MD, MSc, Clinical Investigator - October 24, 2016

An FDA inspection of Monica M. Mita, M.D., a clinical investigator in Los Angeles, revealed significant deviations from investigational plans and regulatory requirements. Observations included failure to follow the study protocol for subject dosing, inadequate and inaccurate case histories with unreported adverse events and concomitant medications, and issues with informed consent documentation. These findings indicate a lack of adherence to good clinical practice.