Following CRL, Form 483 reveals more quality issues at Alvotech’s production facility in Iceland
Another Form 483 for the Icelandic biosimilar manufacturer Alvotech’s manufacturing facility has shed more light on a recent complete response letter from the FDA that’s stalling the company’s potential new Humira competitor.
The 12-page report, based on the FDA’s inspection from March, found eight observations at Alvotech’s production site in the Icelandic capital of Reykjavik — most of them different from last year’s inspection. This report stated that Alvotech’s quality unit was not effective in carrying out duties to ensure that drug products had good manufacturing practices.
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