Novo Nordisk’s US semaglutide manufacturing site under the spotlight again as 2022 monitoring issue surfaces
Novo Nordisk’s US facility has had at least four quality control issues related to microbes in the past two years. Its Clayton, NC site manufactures the company’s active pharmaceutical ingredient semaglutide, used in its blockbuster diabetes and weight loss drugs.
Manufacturing concerns surrounding “objectionable organisms” first came to light on Monday, when Market Wire reported the company received a Form 483 which detailed issues on three separate occasions this year. A fourth instance, as reported by Reuters on Wednesday, notes a similar issue in May 2022.
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