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Remediation: The Independent Assessment: The FDA mandated a "comprehensive, independent assessment of all laboratory computer systems".4 This requirement for an independent assessment underscores the agency's lack of confidence in the firm's internal IT and QA competence

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More recently MCs from liver have been have been purified on an iodixanol density barrier of approx = 1.084 g/ml [9,10] or banded between a two-layer gradient of 1.051 and 1.077 g/ml [11]