FDA 483 - J. Scott Ferguson, MD - November 22, 2024

An FDA inspection of J. Scott Ferguson, MD in Madison, WI, a clinical investigator, revealed that an investigation for the SPRAY-CB study was not conducted in accordance with the signed agreement, investigational plan, and applicable FDA regulations. Specifically, under-performing catheters were not returned to the sponsor for evaluation, and data integrity was compromised as the study coordinator completed subject questionnaires instead of the subjects themselves.