FDA 483 - Manuel F. Fernandez, M.D. - February 17, 2023

Manuel F. Fernandez, M.D. in Miami, FL, received an FDA Form 483 for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. The inspection revealed that four subjects were randomized and received investigational product despite not meeting the protocol's inclusion criteria. Additionally, one subject's pre-visit diaries did not meet the specified inclusion criteria.