FDA 483 - Kathryn Lucas, M.D. - April 08, 2016

An FDA inspection of Kathryn J. Lucas, M.D. in Morehead City, NC, identified a significant deviation from the investigational plan for a Type 1 diabetes study. The firm enrolled subjects who did not meet the protocol's eligibility criteria regarding their diabetes diagnosis type and prior medication use. This failure to adhere to the study protocol raises concerns about the integrity of the clinical trial data.