FDA 483 - Haris Ali, M.D. - September 30, 2022

The FDA inspected Haris Ali, M.D., a clinical investigator in Duarte, CA, and identified significant deviations from the investigational plan. Observations included failures to report serious adverse events to the sponsor in a timely manner, administering investigational product when it should have been held, and numerous instances of missed protocol-required events for multiple study subjects. These findings indicate a lack of adherence to study protocols and regulatory requirements for clinical investigations.