COPENHAGEN, March 10 (Reuters) - Novo Nordisk said on Tuesday that it had received a warning letter from the U.S. Food and Drug Administration (FDA) regarding an inspection at the Danish drugmaker's
Novo Nordisk receives FDA warning linked to US inspection in 2025
FDA Warning and Company Response
Details of the FDA Warning Letter
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.
Action Plan and Compliance Measures
The company has undertaken an action plan that includes addressing gaps in its capability to prevent adverse effects or any other drug-related problems once the medicines are on the market, it said. It has also kept the agency informed on the progress.
FDA's Request for Additional Details
"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.
Although the inspection took place in 2025, the warning letter was issued in early March.
Timeline and Additional Inspections
Initial Response and Ongoing Updates
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.
Second Letter and Broader FDA Actions
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.
FDA's Review Process
"For all inspections, FDA takes the time necessary to thoroughly review and analyze all factors in the case and the associated evidence. Once a determination of a violation is found, FDA takes appropriate action to uphold its public health mission," an HHS spokesperson said in an emailed statement.
Company Outlook and Impact
Novo said it was confident that it will resolve the matter to the agency's satisfaction.
The company does not expect the development to have any impact on its production or forecast unveiled earlier this year.
(Reporting by Louise Rasmussen in Copenhagen, Mrinalika Roy and Sriparna Roy in Bengaluru editing by Terje Solsvik and Sriraj Kalluvila)
