FDA 483 - Kathryn Lucas, M.D. - December 13, 2022

Kathryn Lucas, M.D. in Morehead City, NC, was inspected from November 14 to December 13, 2022, and received a Form FDA 483 with two observations. The inspection revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan, specifically regarding blood pressure reading procedures and vital data documentation. Additionally, the firm failed to prepare or maintain accurate case histories, as blood pressure readings were entered into electronic records prior to being taken.