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

An FDA surveillance inspection was conducted at Kathryn Lucas, M.D. (Lucas Research) from August 21 to August 27, 2018. This inspection, carried out under Compliance Program 7348.811 for Clinical Investigators by the Center for Drug Evaluation and Research, aimed to assess Dr. Lucas's adherence to investigational protocols for two drug trials. This was the third FDA inspection for the site, with previous inspections in 2015 and 2016 also classified as "Voluntary Action Indicated" (VAI) for issues such as not following investigational plans and inadequate case histories or enrolling ineligible subjects. During the current inspection, two primary violations were identified and documented on a Form FDA 483. First, the investigation was not conducted in accordance with the investigational plan. Second, there was a failure to prepare or maintain adequate and accurate case histories, including observations, pertinent data, and informed consent. Management acknowledged the observations and committed to submitting a response with promised corrections within 15 business days. The inspection concluded with a "Voluntary Action Indicated" classification, signifying that regulatory follow-up beyond the promised corrections is not immediately mandated.