FDA 483 - Syed Ali, M.D. - July 03, 2025

An FDA inspection of Syed O. Ali, M.D. in Sugar Land, TX, a clinical investigator, revealed a significant deficiency in the conduct of an investigation. The firm failed to adhere to the investigational plan, specifically by improperly randomizing subjects who did not meet screening criteria and by not completing all required screening safety labs prior to determining subject eligibility. These issues indicate a lack of proper oversight in clinical trial execution.