Alvotech (NASDAQ:ALVO) announced Monday that the U.S. Food and Drug Administration (FDA) has completed a routine cGMP (current Good Manufacturing Practice) surveillance inspection at its Reykjavik, Iceland, facility.
The audit, which concluded on May 8, 2026, resulted in the issuance of a Form 483.
A Form 483 is issued when investigators observe conditions that may constitute violations of federal requirements.
However, Alvotech characterized the findings as addressable and stated they do not raise substantial issues regarding the site’s fundamental operations.
The company believes it can resolve the observations quickly, citing the “robustness of improvements” implemented at the facility over the past year.
The successful conclusion of the inspection is a critical step for Alvotech as it prepares to resubmit Biologics License Applications (BLAs) for several biosimilar candidates.
The company confirmed it remains on track to refile these applications within the second quarter of 2026 and continues to anticipate FDA approvals before the end of the year.
The Reykjavik site is central to Alvotech’s vertically integrated model, handling the development and manufacture of its entire portfolio, including biosimilars for blockbuster drugs like Humira and Stelara.
Maintaining the facility’s compliance status is vital for the company’s 2026 commercial launch strategy in the United States.