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A Form 483 is issued to management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. DepositPhotos/[email protected] Lars Otto Andersen-Lange, Novo Nordisks director of media relations, told us: Following the FDAs inspection in July 2023, we have responded to their observations and the site is running and producing for the market. Novo Nordisk set up the Clayton facility in 2016, explaining the $1.8 billion, 417,639 square-foot site would produce APIs for a range of its current and future GLP-1 and insulin medicines

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