FDA 483 - Bertrand P. Cole, D.O. - May 16, 2025

An FDA inspection of Bertrand P. Cole, D.O., a clinical investigator in Portsmouth, NH, revealed a significant deviation in the conduct of a clinical study. All four subjects in the study were repeatedly overdosed with the Investigational Product, leading to adverse reactions and the interruption of their treatment. This issue stemmed from a failure to follow drug handling instructions and the protocol's titration regimen.