Novo Nordisk received a warning from the Food and Drug Administration for failing to report suspected incidents of side effects caused by its medicines, a step that is required by federal law.
In a March 5 warning letter, the agency criticized the pharmaceutical company for various procedures that result in “serious violations” related to the reporting of side effects. The problems were initially discovered during an inspection of Novo Nordisk facilities in early 2025.
Although the inspection focused on compliance for a sample of products, the agency noted that “based on the nature of the inspection’s findings and your written response and correspondence, we have serious concerns about the scope and impact of these violations on your entire product portfolio.”
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