FDA 483 - Syed K. Lateef, M.D. - June 02, 2023

An FDA inspection of Syed K. Lateef, M.D., a clinical investigator in Kissimmee, FL, revealed significant deficiencies in the conduct of a clinical study. The firm failed to adhere to the investigational plan by not ensuring subjects met all eligibility criteria. Specifically, required screening tests were not performed for four subjects, resulting in three ineligible subjects being dosed with investigational product.