Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDr. Smitha C. Reddy at ACRC Studies, LLC failed to conduct clinical drug investigations in accordance with FDA regulations during inspections conducted in August 2021. The primary violations included failure to ensure studies were conducted according to the investigational plan, specifically failing to ensure subjects received their assigned investigational drugs and failing to maintain required blinding of study staff to prevent bias in at least two clinical protocols. These deficiencies violated 21 CFR 312.60 and related requirements governing the protection of human subjects in clinical research.