FDA 483 - Mitali Wadekar, M.D. - February 01, 2019

An FDA inspection of Mitali Wadekar, M.D. in Panorama City, CA, revealed significant deficiencies in the conduct of a human clinical study involving an investigational drug. The clinical investigator failed to adhere to the investigational plan, leading to multiple protocol deviations. These issues included under-dosing of study participants, failure to perform required urine drug screens, improper storage of study drug outside specified temperature ranges, and a missed blood chemistry panel.