COPENHAGEN, March 10 (Reuters) – Novo Nordisk said on Tuesday it had received a warning letter from the U.S. Food and Drug Administration regarding an inspection at the Danish drugmaker’s site in Plainsboro, New Jersey in early 2025.
The company said it has undertaken a corrective and preventative action plan and has kept the agency informed on its progress.
The letter, which the company received on March 6, related to a post-marketing adverse drug experience inspection conducted at the site.
“The Warning Letter largely seeks additional details on these measures to confirm current and future regulatory compliance; it does not make any conclusions about the quality or safety of our medicines,” the company said.
Novo first responded to the Form FDA 483, a type of inspectional observation document, within the agency’s deadline, on March 3, 2025, and has shared seven updates since then.
The drugmaker also said it received a second letter related to a Good Manufacturing Practice inspection at the site in Bloomington, Indiana in late 2025.
The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for additional details about the inspections and the contents of the letters.
Novo said it was confident that it will resolve the matters outlined in the warning letter to the agency’s satisfaction.
The company does not expect the development to have any impact on its production or forecast shared earlier this year.
(Reporting by Louise Rasmussen in Copenhagen, Mrinalika Roy and Sriparna Roy in Bengaluru editing by Terje Solsvik and Sriraj Kalluvila)
