FDA 483 - Sant P. Chawla, MD - April 15, 2022

An FDA inspection of Sant P. Chawla, MD, Clinical Investigator, in Santa Monica, CA, revealed a significant protocol deviation during a human clinical study. The investigator failed to immediately hold a subject's investigational drug despite becoming aware of abnormal laboratory results, leading to the subject continuing the drug for several days and subsequently being hospitalized with serious conditions. This indicates a critical failure in patient safety and adherence to the investigational plan.