FDA EIR - Karen D. Wright, M.D. - October 18, 2021

This FDA establishment inspection of Karen D. Wright, M.D., located in Boston, MA, was conducted from October 6 to October 18, 2021. The inspection was a comprehensive surveillance review of Dr. Wright's role as a sponsor-investigator for two clinical studies, under the regulatory frameworks of Compliance Programs 7348.810 and 7348.811, which cover sponsors, contract research organizations, and clinical/sponsor-investigators. The review focused on Dr. Wright’s oversight of the studies, including Institutional Review Board correspondence and approvals, monitoring reports, study protocols, staff training documentation, informed consent forms, and subject data. This marked the first FDA inspection for Dr. Wright. Notably, no formal Form FDA 483 Inspectional Observations were issued. However, during the closing discussion with management, a verbal observation was made regarding incomplete documentation: records of training provided to external clinical sites did not consistently identify the individuals who delivered the training. Dr. Wright acknowledged the importance of this documentation and agreed to address this administrative detail. The inspection concluded without any refusals or samples collected.