Novo Nordisk PADE Reporting Violations

A 1/13-2/7/2025 FDA inspection at the Novo Nordisk facility in Plainsboro, NJ, identified serious violations of postmarketing adverse drug experience (PADE) reporting requirements. A 3/5 Warning Letter cites several examples of how Novo Nordisk failed to develop written procedures for the surveillance, receipt, evaluation, and reporting of PADEs.

The letter acknowledges the firm’s corrective and preventive actions since the inspection, but says its response to the inspection observation is inadequate because it did not provide sufficient details to determine whether its actions will effectively prevent similar violations in the future.

“Your failure to develop procedures that ensure the submission of 15-day Alert reports, and the prompt investigation of ADEs that were the subject of 15-day Alert reports, raises significant concerns about your ability to accurately and completely report product safety information to FDA in accordance with PADE requirements,” FDA says.