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Talk to a SpecialistTalk to a SpecialistXoran Technologies manufactured computed tomography (CT) systems and supporting software (MiniCAT 2020, MiniCAT IQ, xCAT IQ, xCAT XL, and XoranConnect) that were found to be adulterated due to non-conformity with Current Good Manufacturing Practice requirements under 21 CFR Part 820. During a June-July 2024 inspection, the FDA identified multiple Quality System regulation violations, including failure to establish and maintain procedures ensuring purchased products and services conform to specified requirements, as required by 21 CFR 820.50, and specifically the company's failure to implement supplier approval procedures requiring completion of the Supplier Self-Assessment form. The company submitted responses to the FDA's initial inspection observations in July, August, and September 2024, but the violations were not resolved to FDA satisfaction.