FDA 483 - Rosa M. Suarez, M.D. - March 10, 2023

Rosa M. Suarez, Clinical Investigator, received a Form 483 following an FDA inspection in Miami, FL, citing significant deviations in clinical trial conduct. Observations included failures to adhere to investigational plans, such as enrolling subjects who did not meet criteria, incorrect product randomization and administration, and inadequate case histories. Additionally, informed consent procedures were not properly followed, with some protocol-specific procedures performed before subjects signed consent forms.