Alvotech announces successful closure of FDA inspection of manufacturing facility
The FDA closed its inspection of Alvotech’s Reykjavik manufacturing facility, conducted in May 2026, assigning the site a Voluntary Action Indicated (VAI) classification. CEO Lisa Graver stated that the milestone reflects strengthened quality systems and that the company has effectively addressed prior observations, allowing it to advance Biologics License Applications.
Key figures
- Approved marketed
- 5
- Pipeline candidates
- 13
AI analysis
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