FDA 483 - Marina Nikanorova, M.D.

This FDA Form 483 was issued to Marina Nikanorova, M.D., a clinical investigator in Dianalund, Denmark, following an inspection related to a clinical trial for Dravet Syndrome. The inspection revealed significant deficiencies in record-keeping for efficacy endpoints, failures in obtaining informed consent under non-coercive circumstances, and improper documentation of consent forms. These issues indicate a lack of adherence to investigational plans and proper clinical trial conduct.