The FDA has issued a warning letter to Novo Nordisk after a PADE inspection identified deficiencies in the company’s post-marketing adverse event reporting and pharmacovigilance systems.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Novo Nordisk after identifying problems in the company’s system for monitoring and reporting post-marketing adverse drug events.
The action follows a Post-marketing Adverse Drug Experience (PADE) inspection conducted between January 13 and February 7, 2025, at Novo Nordisk’s U.S. headquarters in Plainsboro, New Jersey. During the inspection, FDA investigators evaluated whether the company was meeting its legal obligations to track and report safety issues linked to its approved medicines.
According to the FDA, the inspection found violations of requirements under the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.80, which require drug manufacturers to monitor, assess, and promptly report adverse drug experiences after their products are on the market.
Issues Identified During the Inspection
The FDA said Novo Nordisk did not maintain adequate procedures for how post-marketing adverse events should be received, evaluated, and reported. Investigators also found delays in submitting serious adverse event reports within the required timelines.
In addition, some safety reports were rejected or invalidated without sufficient justification, and certain cases remained under internal medical review for extended periods, which delayed their submission to the FDA.
During the inspection, investigators also identified several examples of safety reports that were not handled appropriately. These included a case involving a stroke that left a patient disabled while receiving liraglutide, as well as reports of deaths in patients treated with semaglutide that were either invalidated or not reported to the FDA. Another report involving suicidal ideation in a patient taking semaglutide was not reviewed or submitted to the agency within the required timeframe.
The FDA said these examples reflect broader weaknesses in the company’s systems for assessing and reporting post-marketing safety events.
The agency also noted that Novo Nordisk’s earlier responses to inspection findings did not fully address the underlying causes of the problems or provide sufficient detail on how the company would correct them. As a result, the FDA issued the warning letter and asked the company to submit a detailed corrective action plan within 15 working days explaining how it will resolve the issues and ensure compliance with regulatory requirements.
Novo Nordisk’s Response
Novo Nordisk acknowledged receiving the warning letter and said it has been working to address the FDA’s concerns since the company received the Form FDA 483 following the 2025 inspection.
The company stated that it has already introduced corrective and preventive measures to strengthen its pharmacovigilance systems and improve how adverse events are monitored and reported.
Novo Nordisk also emphasized that the warning letter does not question the safety, quality, or benefit–risk profile of its medicines. The company said it remains committed to maintaining strong safety monitoring systems and will continue to work with the FDA to address the agency’s concerns.
Regulatory Context
Monitoring the safety of medicines after they are approved is an essential responsibility for pharmaceutical companies. Once a drug is widely used, new safety signals may emerge that were not seen during clinical trials.
Regulators rely on companies to collect, evaluate, and report adverse event data quickly, so potential risks can be identified and managed. FDA warning letters related to pharmacovigilance highlight gaps in these systems and typically require companies to strengthen their safety monitoring processes to ensure patient safety.
References
WARNING LETTER, Novo Nordisk Inc. FDA Ref. No.: 26-HFD-45-03-01, 05 March 2026, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novo-nordisk-inc-717576-03052026
Novo Nordisk acknowledges receipt of Warning Letter and welcomes further dialogue with the US FDA, 10 March 2026, https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916514#
About the Writer
Vennela Reddy, BPharm,
She is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.
