FDA 483 - Kathryn Lucas, M.D. - August 27, 2018

An FDA inspection of Kathryn Lucas, Clinical Investigator, in Morehead City, NC, revealed significant non-compliance with clinical investigational plans and record-keeping. Observations included failures to conduct investigations according to protocol, delayed reporting of serious adverse events, and inadequate maintenance of accurate case histories. These issues indicate a serious lack of adherence to regulatory requirements for clinical trials.