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

An FDA inspection of clinical investigator Dean L. Harris in Christchurch, New Zealand, conducted from May 1 to May 5, 2023, identified two significant deviations from the investigational plan for study (b) (4). Firstly, the study site failed to adhere to the protocol's treatment discontinuation criteria. Two subjects, who had achieved a confirmed complete response, continued to receive investigational product beyond the point mandated by the protocol. Although an ethics committee approved continued treatment via an administrative letter, the committee was not informed about the initial period of unapproved treatment administration until much later. Secondly, the site did not follow the protocol regarding adverse event causality assessment. The worksheets used a limited set of causality codes that differed from the comprehensive list specified in the protocol, a discrepancy that was only identified and triggered a reassessment of prior adverse event causalities in late April 2023. These observations, issued under the FDA's regulatory framework for clinical investigators (Form FDA 483), indicate failures to uphold the approved study protocol. Dean L. Harris is required to address these findings, outlining corrective and preventive actions to ensure compliance with the investigational plan and proper ethical oversight going forward.