© Reuters. FILE PHOTO: Flags are seen outside Novo Nordisk headquarters in Copenhagen, Denmark, February 5, 2020. REUTERS/Jacob Gronholt-Pedersen/File Photo
COPENHAGEN (Reuters) – Novo Nordisk (NYSE:)’s shares fell on Monday after financial news agency MarketWire reported that U.S. drug regulators had recently issued a report detailing quality control lapses at the group’s Clayton, North Carolina plant, citing sources.
Reuters was not immediately able to authenticate the report. Novo Nordisk declined to comment on the report, but said in an emailed statement that the site was “running and producing for the market”.
Clayton is a major site for the company’s production of its active pharmaceutical ingredients, including semaglutide, which is the drug used in its hugely popular weight-loss drug Wegovy and type 2 diabetes drug Ozempic.
Shares in the company were down 3% at 1133 GMT.
MarketWire did not specify when the FDA inspection occurred.
The FDA did not immediately respond to a request for comment from Reuters, and does not typically comment on individual inspections.
The FDA’s inspection dashboard, a public website, was not currently listing any inspections as having occurred this year, but the dashboard is not a comprehensive record of all its inspections.
MarketWire’s article on Monday stated that FDA inspectors had issued a Form 483 following their inspection. According to the FDA, a Form 483 is a type of agency report containing “observations” that FDA inspectors “deem to be objectionable”.
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