Novo Nordisk landed in hot water with the FDA following an inspection at one of the drugmaker’s key semaglutide and insulin manufacturing plants this past spring.
Earlier this year, the FDA issued a Form 483 (PDF) rebuke to Novo Nordisk following an inspection of the company’s production site in Kalundborg, Denmark. Novo uses the site to make its hit GLP-1 drugs for diabetes and obesity, Ozempic and Wegovy, plus the once-weekly insulin icodec product Awiqli.
The regulatory reprimand, dated March 25, was posted on the FDA website on Tuesday. The inspection itself took place during several days in March. The facility walkthrough resulted in 8 observations from the FDA.
Inspectors found the facility lacked records that indicated the water used in drug production was adequately controlled for certain microorganisms.
Additionally, the agency found the facility didn’t have written procedures in place for the production, processing or packing in order to assure identity, strength, quality and purity of a drug substance which had its name redacted in the filing.
Besides the key GLP-1 products, the site is responsible for making Novo's once-weekly insulin icodec, which the FDA declined to approve in July over manufacturing issues, a company spokesperson said in an email to Fierce. Novo's spokesperson said the issues around the insulin product—approved in places like Canada, Europe and Japan as Awiqli—are unlikely to be resolved this year.
The ability of of Novo's GLP-1s to help patients lose weight has been a boon for Ozempic and Wegovy, however, immense mainstream popularity has also resulted in repeated supply shortages in the past few years. To keep up with demand, the company has announced new manufacturing projects in places like Ireland, France and China.
In addition, Novo is pumping about $8.7 billion into the Kalundborg campus through 2029 in a move to boost capacity. The investment is expected to create about 1,200 new jobs on top of the site's current workforce of roughly 4,400.