Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistValley Biosystems violated Good Laboratory Practice (GLP) regulations during FDA inspection of nonclinical studies on biologics conducted between August and October 2021. The company failed to ensure that individuals conducting or supervising laboratory studies possessed adequate education, training, and experience for their assigned functions, as required under 21 CFR Part 58. The inspection was conducted under the Bioresearch Monitoring Program, which evaluates the scientific validity and accuracy of research data for investigational products.