FDA warns Genzyme's Irish site over quality questions

July 1, 2026 02:07 PM EDT FDA+Manufacturing FDA warns Gen­zyme's Irish site over qual­i­ty ques­tions Zachary Brennan Senior Editor An FDA warn­ing let­ter sent late last month to Gen­zyme’s Ire­land-based man­u­fac­tur­ing site, now owned by Sanofi, rais­es sig­nif­i­cant qual­i­ty- and da­ta-re­lat­ed is­sues. On da­ta … Sign up to read this article for free. Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox. SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER