An Ozempic and Wegovy factory in North Carolina that helps serve millions of Americans failed an inspection, reports suggest.
The Food and Drug Administration (FDA) deemed the factory to have “objectionable” conditions.
Based in Clayton, North Carolina, the drugmaker now has three weeks to devise an action plan to rectify the problems or risk facing further action. Novo Nordisk, the factory’s owner, says manufacturing is “ongoing.”
The Danish company behind the hit weight-loss drugs Ozempic and Wegovy has been rapidly expanding its manufacturing capacity to meet growing demand, with five million prescriptions for its weight-loss drugs written in the U.S. alone on last year.
This surge caused major drug shortages earlier this year, prompting pharmacies to mix up their own versions.
Novo Nordisk now has three weeks to devise an action plan to rectify the issues or risk facing further actions. The photo above shows their manufacturing plant.
Novo Nordisk’s share price fell almost three percent on Monday, before rising to $187.63 per share.
The report, of financial news agency Market news Citing sources, he said the factory was given a Form 483.
This is granted to companies when inspectors from the FDA’s Office of Regulatory Affairs observe conditions at manufacturing facilities that they deem “objectionable.”
The reason Novo Nordisk issued the form has not been made public, but some objectionable conditions listed on Form 483 include dirty or damaged equipment, failure to properly store medications, or insufficient documentation.
FDA inspectors are believed to have visited the country as part of a routine inspection, which the agency conducts to ensure factories meet its standards.
When the report was revealed, the company’s stock price fell three percent, although it has now recovered to $187.63 per share.
Novo Nordisk’s Clayton site includes a plant responsible for manufacturing semaglutide, the active ingredient in Wegovy and Ozempic.
This plant opened in 2021 and was the first site outside Denmark that the company built to manufacture the drug. It is approximately 400,000 square feet, or the size of seven football fields.
There is also a second plant that handles the assembly and packaging of medicines, including Ozempic and Wegovy.
These factories are believed to be behind a large portion of the US supply of Ozempic and Wegovy, and disruption at the facilities risks drug shortages.
Currently, the FDA still lists four semaglutide injections (three for Wegovy and one for Ozempic) as having limited availability.
Two Ozempic injections are also listed as “currently available.”
Denmark-based Novo Nordisk declined to comment on the reports but said the factory was still “operating and producing for the market.”
The FDA did not respond to requests for comment, but it does not typically comment on individual companies.
Novo Nordisk also has a third factory in the Durham area, 40 miles away, representing a tablet version of semaglutide, sold under the brand name Rybelsus.
Ozempic has taken America by storm with its promise to help someone lose weight with just one shot a week.
Approved to treat type 2 diabetes, the drug is also prescribed off-label to other people to help them lose weight.
It works by suppressing feelings of hunger and slowing down the digestive system, causing someone to eat less because they feel fuller for longer. This causes weight loss.
It comes after analysis revealed that Ozempic, Wegovy and Rybelsus are up to ten times more expensive in the United States than in other wealthy countries.
A price analysis in 10 countries by the Kaiser Family Foundation (KFF) found that 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 from $936 in the US.
A list price is the cost that the drug manufacturer publicly sets when selling it to wholesalers, who buy drugs from the manufacturers to sell in 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 set by manufacturers.