FDA 483 - Eduardo Yanez Ruiz - January 22, 2026

Between January 12 and January 22, 2026, the FDA conducted a foreign surveillance inspection of clinical investigator Eduardo Patricio Yáñez Ruiz, MD, at the James Lind Centro de Investigación del Cáncer in Temuco, Chile. This inspection was performed under the regulatory framework of the Food, Drug, and Cosmetic Act and clinical trial compliance programs to evaluate data supporting two Biologic License Applications. The primary violation, documented in a Form FDA 483, involved the enrollment of multiple subjects who did not meet specific protocol eligibility criteria. Specifically, the site enrolled individuals who lacked mandatory Hepatitis C screening, exhibited insufficient liver function, or had not met the required 12-month waiting period following previous chemotherapy treatments. Additionally, the investigator was cited for several procedural deficiencies, including a lack of formal systems for tracking and reporting protocol deviations, significant legibility issues in handwritten medical records that hindered data interpretation, and the use of outdated or incomplete informed consent forms. Dr. Yáñez acknowledged the findings, attributing the enrollment errors to a misunderstanding of the protocol requirements. As a required action, the investigator must submit a formal written response to the FDA within 15 business days detailing his planned corrective measures. The FDA’s Center for Drug Evaluation and Research will review the response to determine the final compliance classification and whether further administrative or civil actions are necessary.