บันทึกจากแหล่งปฐมภูมิ
The FDA has formally closed its May 2026 inspection of Alvotech’s Reykjavik manufacturing site with a Voluntary Action Indicated (VAI) classification. This resolves the inspection observations and supports the company’s ongoing BLA reviews for AVT05, AVT06, and AVT16.
Alvotech announces successful closure of FDA inspection of manufacturing facility REYKJAVIK, Iceland, July 29, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has closed its inspection of the company’s manufacturing facility in Reykjavik, Iceland, conducted in May 2026. The FDA has confirmed the inspection classification of the manufacturing site is Voluntary Action Indicated (VAI). “This is an important milestone for Alvotech and reflects the significant work our teams have undertaken to further strengthen our quality systems and manufacturing operations,” said Lisa Grave