Alvotech (ALVO) said Monday the US Food and Drug Administration has issued certain observations following a routine surveillance inspection of its manufacturing facility in Reykjavik, Iceland.

"The company believes the observations can be addressed quickly and do not raise any substantial issues with the site or its operations," Alvotech said.

The company is "well positioned" to resubmit the relevant biologics license applications in the ongoing quarter and continues to expect FDA approval for the relevant applications during 2026, it said.