FDA 483 - Eduardo Yanez Ruiz - January 22, 2026

An FDA inspection of Eduardo Patricio Yanez Ruiz, MD, a clinical investigator in Temuco, Chile, revealed a significant failure to conduct investigations according to the signed statement of investigator. Multiple subjects were improperly enrolled in two clinical studies, as they did not meet all inclusion criteria or met an exclusion criterion. This indicates a serious lapse in adherence to study protocols and patient eligibility.