GENZYME IRELAND LIMITED

FDA Warning Letter to Genzyme Ireland Raises Supply Chain Alarm for Altuviiio Clinical Trials

- The FDA issued a Warning Letter to Sanofi's Genzyme Ireland facility on June 22, 2026, following CGMP violations found during a January 2026 inspection of the Waterford site manufacturing Altuviiio. - Quality problems account for 62% of drug supply chain disruptions, and the Warning Letter directly threatens the multinational LIBERTY roll-over study providing continued Altuviiio access to hemophilia A patients. - Clinical sites are urged to immediately verify IP stock levels against 60-day projected visits and document all supply inquiries in the TMF to mitigate protocol deviation risks. - This marks the second FDA Warning Letter to a Sanofi manufacturing subsidiary within 18 months, signaling a systemic quality governance concern requiring formal vendor risk stratification across all active INDs.