FDA 483 - Moraima Trujillo, M.D. - December 18, 2025

An FDA inspection of Moraima Trujillo, Clinical Investigator, in Homestead, FL, from December 10-18, 2025, revealed significant deficiencies in clinical trial conduct. Observations included failures to maintain adequate and accurate case histories with unsupported data entries, and the investigation not being conducted in accordance with the signed statement of investigator and investigational plan due to a subject not meeting inclusion/exclusion criteria.