FDA 483 - Genzyme Ireland Limited - January 20, 2026

Genzyme Ireland Limited, a drug product manufacturer in Waterford, Ireland, was cited for significant deficiencies across its quality control, manufacturing, and facility maintenance. The inspection revealed issues with data integrity, inadequate investigation of deviations and batch failures, poor facility upkeep including active leaks and rust, and improper equipment cleaning. These findings indicate a systemic failure to adhere to Good Manufacturing Practices, potentially impacting product quality and safety.