FDA 483 - Evelyn Lopez-Brignoni, M.D. - June 23, 2020

Evelyn Lopez-Brignoni, M.D., a clinical investigator in Palmetto Bay, FL, was cited for significant deviations during clinical studies. The firm failed to conduct investigations in accordance with the investigational plan, including issues with investigational product dosing, subject inclusion criteria, and pharmacokinetic blood sample collection. Additionally, the firm did not prepare or maintain accurate case histories, specifically regarding investigational product compliance calculations.