Alvotech Announces Completion of U.S. Food and Drug Administration Surveillance Inspection At Reykjavik Facility

Published: 2026-05-11 11:54:25 ET ALVO

Published on 05/11/2026 at 11:54 am EDT

Alvotech announced that the U.S. Food and Drug Administration (FDA) has completed a routine cGMP surveillance inspection of the company?s manufacturing facility in Reykjavik, Iceland. At the conclusion of the inspection on May 8, 2026, the FDA issued a Form 483. The company believes the observations can be addressed quickly and do not raise any substantial issues with the site or its operations.

Based on the outcome of the inspection, Alvotech is well positioned to resubmit the relevant Biologics License Applications this quarter, once the final data have been compiled. More importantly, the company believes the outcome of this inspection demonstrates the strong cGMP fundamentals of the site and the robustness of all the improvements the company has implemented since last year. Alvotech continues to expect FDA approval for the relevant BLAs during 2026.