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JMCP 27(3):354366 Trogdon JG, Finkelstein EA, Hylands T, Dellea PS, Kamal-Bahl SJ (2008) Indirect costs of obesity: a review of the current literature

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FDA noted that one of the incoming components used in its manufacturing is known to be high-risk for contamination and Sante relied on the supplier's certificate of analysis rather than conducting its own testing to ensure the component met requirements