Novo Nordisk Inc.
FDA issued a Warning Letter to Novo Nordisk Inc. (NNI) following a January–February 2025 inspection that revealed serious violations of postmarketing adverse drug experience (PADE) reporting regulations under 21 CFR 314.80, affecting products including semaglutide and liraglutide. NNI failed to develop adequate written procedures ensuring timely 15-day Alert reporting of serious and unexpected ADEs, improperly rejected reportable cases based on reporter-assessed causality, and failed to promptly investigate ADEs subject to expedited reporting. FDA found systemic failures in NNI's pharmacovigilance program—including inadequate vendor oversight and corrective actions—and requires a written response within 15 business days detailing remediation steps, with the warning that failure to adequately address these issues may lead to further regulatory action.
Flagged claims (5)
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."
a physician reported to your company representative that a patient taking semaglutide was depressed and committed suicide. You failed to document any attempt to obtain additional information from the reporter, including patient identifiers. As of the date of issuance of this letter, this case has not been submitted to FDA.
Argus Case #1171264 includes a non-health care professional reporting the death of a patient receiving semaglutide; however, you failed to promptly investigate because consent was not obtained from the reporter and the reporter was a non-health care professional, as stated in your written procedure. This case was closed without your reporting it to FDA.
you did not require follow-up on reported ADEs if consent was not obtained from the reporter and if the reporter was a non-health care professional
your written procedure did not ensure that you, and the call-center contractors acting on your behalf, correctly received, reviewed, and processed ADE information, which resulted in the failure to submit serious and unexpected ADEs that were required to be reported to FDA within 15 calendar days
Required actions (3)
Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future.
For each major deviation that may affect compliance with PADE regulations and that has a Quality Assurance approval date after 01 Jan 2021, including those listed on the Deviations Handling request provided to the investigators during the inspection, you should submit a description of the deviation, date of identification, current status, the root-cause analysis, an assessment of the impact, the status of all corrective and preventive actions, and the timeline and results for effectiveness checks.
Failure to address this matter adequately may lead to regulatory action.
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