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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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endpoints.newsStai leggendo7 h fa

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.

originale

fiercepharma.com7 h fa

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…

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mercoledì 1 luglio 2026·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.
mercoledì 1 luglio 2026·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…