FDA 483 - Hans C. Lee, M.D. - January 10, 2020

An FDA inspection of Hans Lee, M.D., a clinical investigator in Houston, TX, revealed a significant deviation from the investigational plan. The firm failed to properly conduct an investigation, specifically regarding the incorrect dosing of multiple subjects in a study. This resulted in at least 7 out of 15 subjects receiving improper study drug dosages, contrary to the protocol's requirements for holding or reducing the drug.