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 site in Plainsboro in early 2025.
The company said it has undertaken a corrective and preventative action plan and kept the agency informed on its progress.
Novo said it remains 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, editing by Terje Solsvik and Sriraj Kalluvila)
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