FDA Flags Manufacturing Shortfalls at Novo Nordisk’s North Carolina Plant, Impact on Drug Supply Uncertain

September 19, 2023

Novo Nordisk’s shares have dropped after the FDA reported manufacturing deficiencies at the company’s Clayton, North Carolina plant, which produces vital ingredient ingredients like semaglutide. From July 6 to 13, 2023, the FDA inspected the plant and criticized Novo for quality control lapses, including failing to investigate unexplained batch discrepancies and poor microbial controls thoroughly. These discrepancies included finding objectionable organisms during in-process testing of semaglutide. While it’s still being determined how these issues will affect the supply of Novo’s drugs Ozempic and Wegovy, a company spokesperson assured that the Clayton site is operational and producing. The plant has seen significant expansion, including a $2 billion facility that opened in 2021. It is Novo’s first manufacturing site outside Denmark to produce active pharmaceutical ingredients.

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[Source: Fierce Pharma, September 19th, 2023]

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