Ozempic and Wegovy factory in North Carolina FAILS FDA inspection

• Novo Nordisk stock drops 3%, then rebounds
• Report says conditions at North Carolina factory were ‘uncomfortable’
• Read more: How Ozempic costs up to 10 times more in the US

According to reports, factories in Ozempic and Wegobee, North Carolina, which serve millions of Americans, have failed inspections.

The plant was found to have “unpleasant” conditions by the Food and Drug Administration (FDA).

The Clayton, North Carolina-based drug company has three weeks to develop a plan of action to remediate the issues and risks facing further action. Novo Nordisk, which owns the factory, says production is “ongoing.”

The Danish company that developed blockbuster weight loss drugs Ozempic and Wegoby is rapidly expanding manufacturing capacity to meet surging demand, and in the last year alone, more prescriptions for its weight loss drugs have been sold in the United States. reached 5 million.

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

The report is Keizai Tsushinsha Marketwire News The factory has been given Form 483, sources said.

This is given to companies when inspectors from the FDA’s Office of Regulatory Affairs observe conditions at a manufacturing facility and determine them to be “objectionable.”

Unfavorable conditions listed on Form 483 include dirty or damaged equipment, failure to properly store medications, and inadequate documentation. Novo Nordisk’s reasons for issuing this form were not made public.

FDA inspectors are believed to have visited the facility as part of the agency’s routine inspections to ensure factories are complying with standards.

The company’s stock price fell 3% after the report was revealed, but has now recovered to $187.63 per share.

Novo Nordisk’s site in Clayton includes two plants, one that manufactures and packages diabetes and obesity treatments, and the other that produces semaglutide, the active ingredient in Wigovy and Ozempic.

A third plant near Durham, North Carolina, is preparing to package drugs and make tablets for the first treatment for type II diabetes.

These plants are believed to support much of the U.S. supply of Ozempic and Wegoby, and any disruption to the facilities caused by Form 483 could slow operations and cause further drug shortages.

The FDA still lists four semaglutide injections (three for Wegovy and one for Ozempic) with limited availability.

Ozempic’s two shots are also listed as “currently available.”

Denmark-based Novo Nordisk declined to comment on the report, but said its factories were still “operating and producing for the market.”

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

Ozempic is gaining popularity in the United States because it can help people lose weight with a once-a-week injection.

This drug is approved to treat type 2 diabetes, but is prescribed off-label to help people lose weight.

By suppressing hunger and slowing down your digestive system, you’ll feel fuller longer, so you’ll eat less.

Ozempic and Wegovy are available in countries around the world, but they are up to 10 times more expensive in the United States than in other wealthy countries.

The Kaiser Family Foundation (KFF) analyzed prices in 10 countries and found that a one-month supply of Ozempic costs $936 in the United States.

List price is the cost that drug manufacturers publicly set when selling to wholesalers who buy drugs from manufacturers for sale to pharmacies, hospitals, and clinics.

List prices do not necessarily reflect what consumers will pay, but patients often have to pay more to offset the price set by the manufacturer.