US authorities find flaws at Novo Nordisk facility

During a March inspection of Novo Nordisk’s Kalundborg factory in Denmark, the FDA identified several deficiencies in quality assurance methods. An inspection report obtained by MarketWire details eight observations made by the FDA. The FDA’s concerns include insufficient written procedures to ensure the identity, strength, quality, and purity of drug substances. Novo Nordisk, in response to an FDA letter received in July, acknowledges issues with the production process of Awiqli, a weekly insulin treatment. The company does not anticipate resolving the FDA’s concerns regarding Awiqli within the current year. Novo Nordisk has undergone significant growth in recent years, and plans large investments until 2029 to expand the Kalundborg facility, adding about 1000 new employees. In the first half of the year, the company earned approximately 45.5 billion kroner.