Novo Nordisk says Clayton API site still running after reports of Form 483

The US FDA has raised concerns about manufacturing operations at Novo Nordisk’s API facility in Clayton, North Carolina.

According to a search of the US FDA’s database, agency inspectors issued a Form 483 to Novo Nordisk after visiting the facility – which is assigned the FEI number 1000158576 – on July 13.

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.”

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Lars Otto Andersen-Lange, Novo Nordisk’s director of media relations, told us: “Following the FDA’s 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.

Rybelsus facility

“The facility cited in this letter manufactures API for Rybelsus,”  Anderson-Lange told us. Rybelsus (semaglutide) was approved in 2019 by the FDA to improve blood sugar in adults with type 2 diabetes.

Semaglutide is also the active component in the weight-loss drug Wegovy and type 2 diabetes medicine, Ozempic, though – despite media reports – neither Ozempic nor Wegovy is made at Clayton, Anderson-Lange confirmed.

News of the Form 483 follows less than a month after Novo Nordisk revealed that US FDA inspectors had identified problems at a facility operated by Catalent in Brussels where Wegovy injection pens are filled.

According to Reuters, Novo Nordisk has since hired Thermo Fisher as a second contract manufacturer for the drug.

The newswire reported that Thermo is filling the injection pens at its factory in Greenville, North Carolina.

This article was updated on 21 September at 5.13 am.