Ozempic factory fails inspection as demand for the weight loss drug grows

19 September 2023 , 13:05

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The North Carolina site of Danish company Novo Nordisk (Image: Google Maps)

A key pharmaceutical factory has failed an inspection after being found to have 'objectionable' conditions by the Food and Drug Administration (FDA), a new report suggests.

The factory in North Carolina, where blockbuster weightloss drugs Ozempic and Wegovy is made, has been given three weeks to work out a plan to rectify the issues or face further action. In the meantime manufacturing is ongoing.

Novo Nordisk, the Danish company behind the drug, has had to ramp up production to meet soaring demand. Five million prescriptions were written in the US last year.

There were major shortages of the drug earlier this year prompting other pharmaceutical companies to make their own. The report from Market Wire News said the factory was given a Form 483.

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Supplies of the anti-diabetic medication 'Ozempic' could be under threat (AFP via Getty Images)

According to the FDA's website, these are issued over concerns "that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health."

'Objectionable' conditions include dirty or damaged equipment, failure to properly store medications, and inadequate paperwork. The specific reason Novo Nordisk was issued the form has not been made public.

It is believed the FDA inspectors visited the facility as part of a routine inspection. The publication of the report caused a three-point drop in the company's share price.

The Clayton site contains two factories that produce Novo Nordisk drugs. A third factory in nearby Durham, North Carolina, is preparing to produce the first tablet treatment for type II diabetes.

There are fears any disruption to drug production at the factories could further worsen the drug shortages across the US. The FDA currently lists four semaglutide injections — three for Wegovy and one for Ozempic — as having limited availability.

According to a statement from Novo Nordisk: "The site is running and producing for the market."

Charlie Jones