FDA 483 - Novo Nordisk Inc. - January 13, 2025

During an inspection conducted by the FDA from January 13, 2025, to February 7, 2025, Novo Nordisk Inc., located in Plainsboro, NJ, received an FDA Form 483 outlining significant observations related to its post-marketing adverse drug experience reporting systems. The inspection revealed several critical deficiencies. Firstly, the company failed to report over 300 serious and unexpected adverse drug experiences to the FDA within the mandated 15 calendar days, with an additional 700 reports submitted late. These delays stemmed from issues like a "failure to transmit safety events to global safety database" and incorrect evaluation of report validity. Secondly, Novo Nordisk Inc. did not adequately investigate adverse drug experiences that were subject to 15-day reports, specifically failing to conduct required follow-up attempts for serious events such as deaths and completed suicides. Thirdly, at least ten Individual Case Safety Reports (ICSRs) for serious and listed events were not submitted for their respective reporting periods. Finally, the company"s written procedures for the surveillance, receipt, and reporting of post-marketing adverse drug experiences were found to be inadequate. These procedures inhibited necessary investigations, for instance, by stating no outbound follow-up should occur without consent from non-healthcare professional reporters, or by lacking a clear definition of "non-case" reports. These observations highlight significant non-compliance with FDA regulations concerning pharmacovigilance and drug safety reporting. Novo Nordisk Inc. is required to address these deficiencies promptly by implementing robust corrective actions to ensure timely, accurate, and complete reporting and investigation of all adverse drug experiences.