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Michelle Ellern Dr

16 Salpea P, Stratakis CA

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Diaz points to studies showing that the drugs may interfere with the production and secretion of certain hormonal and metabolic factors, possibly disrupting the structural integrity and barrier function of the skin

9 Detailed Analysis of the Violation The "Excel" Problem: The inspection found that "Excel worksheets used to perform chromatogram calculations were not retained" and "several recent Excel spreadsheets used to perform suitability and assay calculations were deleted".9 Excel is a powerful tool, but in a CGMP environment, it is considered "software" that requires validation