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Novo slapped with Warning Letter
Posted 19 March 2026 PM
The FDA has slapped Novo Nordisk with a Warning Letter for unreported semaglutide safety signals, including deaths, with the TGA “considering the issues raised”.
The warning letter relates to a post-marketing adverse drug experience (PADE) inspection conducted at the Plainsboro, New Jersey site in early 2025, which resulted in a Form FDA 483. The FDA issues documents of this nature after an inspection that outlines improper practice or regulatory shortcomings.
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Posted 19 March 2026 PM
The FDA has slapped Novo Nordisk with a Warning Letter for unreported semaglutide safety signals, including deaths, with the TGA “considering the issues raised”.
The warning letter relates to a post-marketing adverse drug experience (PADE) inspection conducted at the Plainsboro, New Jersey site in early 2025, which resulted in a Form FDA 483. The FDA issues documents of this nature after an inspection that outlines improper practice or regulatory shortcomings.
To see the whole article, please login
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