FDA WARNING_LETTER - Novo Nordisk Inc. - February 07, 2025

Novo Nordisk Inc. (NNI) received an FDA Warning Letter dated March 5, 2026, following an inspection from January 13 to February 7, 2025. The inspection revealed serious violations of postmarketing adverse drug experience (PADE) reporting requirements under section 505(k) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.80. Key issues included NNI"s failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of ADEs. Specifically, procedures improperly allowed the rejection of serious and unexpected ADEs if a reporter deemed them unrelated to the product, contrary to FDA regulations. The company also inappropriately invalidated 15-day Alert reports due to a perceived lack of patient identifiers, despite available information, and failed to complete medical reviews within its own specified timelines, delaying critical report submissions. Furthermore, NNI"s procedures did not ensure prompt investigation of 15-day Alert reports, requiring unnecessary consent from non-healthcare professional reporters for follow-up, and failing to document investigation attempts for serious cases like patient deaths. The FDA noted NNI"s corrective actions were insufficient, indicating systemic failures in monitoring product safety, including vendor oversight. NNI must provide a detailed written response within 15 business days outlining effective preventive measures and addressing all identified deficiencies, including retrospective reviews of deviations.