Novo Nordisk and Alvotech Face Continued FDA Scrutiny at Plants Tied to Recent FDA Rejections

Novo Nordisk and Alvotech both face ongoing FDA scrutiny tied to their manufacturing facilities, with recent inspections and regulatory actions affecting their drug approvals and operations.

Novo Nordisk received multiple FDA warning letters following inspections at U.S. sites in Plainsboro, New Jersey, and Bloomington, Indiana, related to unreported safety signals for Ozempic and systemic manufacturing and quality control deficiencies.

Alvotech’s Reykjavik, Iceland, manufacturing plant drew repeated FDA scrutiny, including Complete Response Letters and Form 483 observations that delayed approvals for biosimilars of EYLEA, Prolia, and SIMPONI.

Both companies emphasize that the issues relate to facility compliance and quality systems rather than product safety, and each has implemented corrective and preventive action plans to address FDA findings and resubmit pending applications by late 2026.