FDA 483 - Filipa Lynce, M.D. - October 21, 2025

Filipa Lynce, M.D., a sponsor-investigator in Boston, MA, was cited for failing to conduct a clinical investigation in accordance with the general investigational plan and protocols specified in the IND. Specifically, the study team enrolled a fourth subject at an incorrect dose level without protocol requirement and failed to adjust subject enrollment based on adverse events like elevated liver enzymes. These issues indicate significant deviations from proper clinical trial conduct.