FDA 483 - Novo Nordisk Inc. - February 07, 2025

An FDA inspection conducted at Novo Nordisk Inc.'s corporate headquarters in Plainsboro, NJ, from January 13 to February 7, 2025, identified significant deficiencies in the company's post-marketing adverse drug experience reporting systems. The inspection revealed that the company failed to report over 300 serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days, with many reports submitted substantially late, some by over a thousand days. This was partly attributed to an internal deviation identified as a "failure to transmit safety events to global safety database" and inadequacies in vendor training for adverse event surveillance, which led to an additional 700 late submissions.

Furthermore, Novo Nordisk Inc. did not promptly investigate these serious and unexpected adverse events, failing to conduct required follow-up attempts with reporters for critical cases involving outcomes like death or completed suicide related to products such as Ozempic. The company also failed to submit at least 10 required periodic Individual Case Safety Reports (ICSRs) for serious and listed events. A key contributing factor was the inadequacy of written procedures for the surveillance, receipt, and reporting of post-marketing adverse drug experiences. Specifically, the company's "Case Management Workflow" SOP was found to hinder necessary investigations and evaluations, and serious events were left uninvestigated due to issues like not obtaining reporter consent or initial rejections by case processors. The regulatory framework violated pertains to timely adverse event reporting requirements.

To address these observations, Novo Nordisk Inc. is required to implement robust corrective actions, ensuring timely and accurate submission of all adverse event reports, enhancing investigation protocols, improving vendor oversight, and revising its procedural documents to comply with regulatory requirements for drug safety reporting.