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  • https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/10%3A_FDA_Enforcement/10.02%3A_Section_2-
    If the label is missing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or nu...If the label is missing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count Additionally, the BIMO serves to determine the accuracy and reliability of clinical trial data submitted to the FDA and to assess compliance with the FDA's regulations governing the conduct of clinical trials.

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