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Sanofi unit in Ireland chided by FDA over manufacturing flubs linked to Altuviiio
After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing further reprimand from the U.S. regulator. | After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing further reprimand from the U.S. regulator.
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endpoints.news
FDA warns Genzyme's Irish site over quality questions
FDA warning letter cites Genzyme's Waterford, Ireland site for data integrity failures and improperly canceled deviations following a January inspection.
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fiercepharma.com
Sanofi unit in Ireland chided by FDA over manufacturing flubs linked to Altuviiio
After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing further reprimand from the U.S. regulator. | After a…
