FDA 483 - Kevin E. Miller, MD - February 13, 2026

An FDA inspection of Cypress Medical Research Center, Llc. in Wichita, KS, revealed three observations related to their clinical investigator activities for the INTIBIA Pivotal Study. The firm allowed subjects to participate prior to IRB approval, failed to conduct the investigation according to the investigational plan, and maintained inaccurate and incomplete subject records. These issues indicate significant deficiencies in study oversight and documentation.