FDA 483 - Yanetsi Flores Landa, M.D. - September 16, 2022

An FDA inspection of Yanetsi Flores Landa, M.D. in North Lauderdale, FL, a clinical investigator, revealed significant deficiencies in the informed consent process for a pediatric study. The firm failed to obtain signed informed consent from subjects' parents or legally authorized representatives prior to initiating study procedures and administering investigational product. Additionally, there was no established process or documentation to verify the parental relationship or legal guardianship for individuals providing consent for minor subjects.