Overview
- An FDA warning letter dated March 5 cites “serious violations” and suggests systemic failures found during a 2025 inspection of Novo Nordisk’s Plainsboro, New Jersey site.
- The letter details unreported or delayed cases including three deaths among semaglutide users — one a suicide — a late-submitted suicidal ideation report, and a disabling stroke on liraglutide that went unreported.
- Regulators faulted procedures that let staff cancel or invalidate adverse event reports over perceived non-causality or missing identifiers, contrary to rules requiring 15-day reporting regardless of causation.
- The action covers multiple products beyond semaglutide, including liraglutide, nedosiran sodium and estradiol, with the FDA indicating other portfolio products could face similar concerns.
- Novo Nordisk says it has filed an initial response plus seven updates and expects no production impact, while the FDA warned of possible further action and reports note the company’s shares are down about 27% year to date.