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Example 2 Your firm failed to test Active Pharmaceutical Ingredients (API) prior to use in manufacturing drug products

Gastroenterol Hepatol Bed Bench 4(3):102108 Rostami Nejad M, Rostami K, Yamaoka Y, Mashayekhi R, Molaei M, Dabiri H, Al Dulaimi D, Mirsattari D, Zojaji H, Norouzinia M, Zali MR (2011b) Clinical and histological presentation of Helicobacter pylori and gluten related gastroenteropathy

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In addition, the formation of tertiary lymphoid organs within this infiltration suggests the presence of an adaptive immune response to persistent foreign or autoimmune antigens [37, 38]

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Susan Punnoose M, Bijimol D, Mathew B (2021) Microwave assisted green synthesis of gold nanoparticles for catalytic degradation of environmental pollutants