FDA 483 - Genzyme Ireland Limited - January 09, 2025

Genzyme Ireland Limited in Waterford, Ireland, a drug product manufacturer, was cited for significant deficiencies in aseptic processing, facility maintenance, and quality control procedures. Observations included failures to prevent microbial contamination of sterile drug products, inadequate maintenance of critical utility systems, and non-adherence to standard operating procedures for data integrity and equipment qualification. These issues indicate a lack of control over critical manufacturing and quality processes.