FDA 483 - Dean L. Harris - May 05, 2023

Dean L. Harris, a clinical investigator in Christchurch, New Zealand, was cited for failing to conduct a study according to the investigational plan. The inspection revealed that subjects continued to receive investigational product past their complete response status, and adverse event causality assessments were not performed according to the protocol's defined codes. These issues indicate significant deviations from the study protocol and a lack of proper oversight.