Alvotech completes FDA inspection at Iceland facility
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Alvotech Announces Completion of FDA Surveillance Inspection at Reykjavik Facility
May 11, 2026 4:30 AM EDT- Company remains on track for BLA resubmissions in the second quarter
REYKJAVIK, Iceland, May 11, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announces that the U.S. Food and Drug Administration (FDA) has completed a routine cGMP surveillance inspection of the companys 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... More
