Ozempic and Wegovy factory in North Carolina FAILS FDA inspection – sending drug manufacturer’s shares plummeting

An Ozempic and Wegovy factory in North Carolina that helps serve millions of Americans has failed an inspection, reports suggest.

The factory was found to have ‘objectionable’ conditions by the Food and Drug Administration (FDA).

Based in Clayton, North Carolina, the drug manufacturer now has three weeks to devise an action plan to rectify the issues or risk facing further action. Novo Nordisk, which owns the factory, says manufacturing is ‘ongoing’.

The Danish company behind the blockbuster weight-loss drugs Ozempic and Wegovy has been rapidly expanding its manufacturing capacity to meet soaring demand — with five million prescriptions for its weight loss medications written in the US last year alone.

This surge led to major shortages of the drugs earlier this year, prompting pharmacies to mix their own versions.

The share price for Novo Nordisk was down nearly three percent Monday, before rallying to $187.63 per share 

The report, from financial news agency Market Wire News citing sources, said the factory was given a Form 483.

This is given to companies when inspectors from the FDA’s Office of Regulatory Affairs observe conditions in manufacturing facilities they deem to be ‘objectionable.’ 

Objectionable conditions listed on Form 483 include dirty or damaged equipment, failure to properly store medications and insufficient paperwork. The reason Novo Nordisk was issued the form has not been made public.

The FDA inspectors are thought to have visited the facility as part of a routine inspection, which the agency does to ensure factories are adhering to its standards.

When the report was revealed, the company’s share price dropped three percent — though it now rallied to $187.63 per share. 

The Novo Nordisk site in Clayton is home to two plants that produce and package diabetes and obesity drugs, as well as manufacture semaglutide, the active ingredient in Wegovy and Ozempic.

A third factory in nearby Durham, North Carolina, packages drugs and is preparing to produce the first tablet treatment for type II diabetes. 

These factories are thought to be behind a large portion of the US supply of Ozempic and Wegovy and any disruption at the facility caused by the Form 483 could delay operations, causing even more shortages of the drugs.

The FDA currently still lists four semaglutide injections — three for Wegovy and one for Ozempic — as having limited availability.

Two Ozempic shots are also listed as ‘currently available’.

Novo Nordisk, based in Denmark, has refused to comment on the reports, but said the factory was still ‘running and producing for the market’.

The FDA did not respond to requests for comment, but does not typically comment on individual companies.

Ozempic has gained gained popularity in America for its promise to help people shed pounds with one injection per week.

While it is approved to treat type 2 diabetes, the medication is being prescribed off-label to help people with weight loss.

It works by suppressing feelings of hunger and slowing the digestive system, leading someone to eat less because they feel full for longer. 

It comes after an analysis revealed Ozempic, Wegovy and Rybelsus are up to ten times more expensive in the US than in other wealthy countries. 

An analysis of prices in 10 countries by the Kaiser Family Foundation (KFF) found a one-month supply of Ozempic — which is approved to treat diabetes but is often prescribed off-label for weight loss — has a list price of $936 in the US.

A list price is the cost the manufacturer of the drug publicly prices it when selling to wholesalers, who purchase drugs from manufacturers to sell to pharmacies, hospitals and clinics.

 While the list price does not necessarily reflect what consumers will pay, patients often need to pay more to offset the price the manufacturers set.