Novo Nordisk Inc. — FDA Warning Letter (March 5, 2026)

Summary

Company

Novo Nordisk Inc.

Letter number

#717576

Issue date

March 5, 2026

Subject

Postmarketing Adverse Drug Experience Reporting Requirements

Word for word, from the letter of March 5, 2026

This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your firm, Novo Nordisk Inc. (hereinafter referred to as NNI), between January 13 and February 7, 2025. The investigators representing FDA reviewed your compliance with postmarketing adverse drug experience (PADE) regulations. The inspection revealed serious violations of PADE reporting requirements found in section 505(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 355(k)] and Title 21, Code of Federal Regulations (21 CFR) 314.80. Failure to comply with section 505(k) is a prohibited act under section 301(e) of the FD&C Act [21 U.S.C. 331(e)].

This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to ensure that accurate, reliable, and timely safety data are submitted to FDA for the monitoring of product safety, and to ensure compliance with PADE regulations.

At the conclusion of the inspection, the investigators presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your written response to the Form FDA 483 dated March 3, 2025, and your subsequent correspondence dated April 11, 2025; May 2, 2025; June 6, 2025; July 11, 2025; September 19, 2025; October 31, 2025; and January 15, 2026.

From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response and correspondence dated March 3, 2025; April 11, 2025; May 2, 2025; June 6, 2025; July 11, 2025; September 19, 2025; October 31, 2025; and January 15, 2026, it appears that you did not adhere to the applicable statutory requirements in the FD&C Act and applicable regulations contained in 21 CFR part 314.

Failure to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) to FDA as required by 21 CFR 314.80(b).

As an application holder of products with active ingredients including semaglutide, liraglutide, nedosiran sodium, and estradiol, NNI is required to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) to FDA. You developed written procedures that failed to ensure that you, and your contractor acting on your behalf, complied with all applicable PADE regulations for the surveillance, receipt, evaluation, and reporting of ADEs.

1. You failed to develop written procedures, as required under 21 CFR 314.80(b), that ensured that you, and your contractor acting on your behalf, reported all serious and unexpected ADEs to FDA within 15 calendar days, in accordance with 21 CFR 314.80(c)(1)(i). PADE regulations require the applicant to report each ADE that is both serious and unexpected, whether foreign or domestic, no later than 15 calendar days from the initial receipt of the information by the applicant (21 CFR 314.80(c)(1)(i)). Specifically:

a. Your written procedure Q014048, “Handling of Adverse Events and Other Safety Information” (Ver: 28.0, Effective Date: 03 Oct 2024), allowed ADEs reported to NNI to be rejected or canceled (and therefore not to be reported to FDA) if the ADE was considered by the reporter to be unrelated to the product. Specifically, Q014048 excludes reports from the definition of “adverse reaction” if “the reporters specifically state that they believe the events to be unrelated or that a causal relationship can be excluded.” This definition is inconsistent with FDA regulations, which define an ADE as “[a]ny adverse event associated with the use of a drug in humans, whether or not considered drug-related.” FDA’s regulations require applicants to develop written procedures for, among other things, the reporting of ADEs regardless of whether the event is considered causally related to the product. An ADE that is determined to be both serious and unexpected must be reported to FDA no later than 15 days from the date of initial receipt. Based on your written procedure, your staff or contractor canceled or rejected serious and unexpected ADEs that were required to be reported within 15 calendar days because they documented these events as being unrelated to the product. For example, Argus1 Case #1331385 involves a consumer who was disabled after experiencing a stroke, which is a serious and unexpected ADE, while receiving liraglutide. The consumer reported that the stroke was not related to liraglutide; therefore, you rejected this case. As a result, you failed to report serious and unexpected ADEs to FDA within 15 calendar days, as required by PADE regulations.

Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novo-nordisk-inc-717576-03052026

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