Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDr. Antonio E. Blanco and Vista Health Research, LLC failed to conduct clinical drug investigations in accordance with FDA regulations and the approved investigational plans, violating 21 CFR 312.60. During an FDA inspection of the clinical site in January 2023, investigators found that Dr. Blanco did not ensure subjects met required inclusion criteria before enrollment and failed to perform mandatory safety procedures as specified in the study protocols. The violations were identified under the FDA's Bioresearch Monitoring Program, which evaluates whether clinical research protects human subjects' rights, safety, and welfare.