FDA 483 - Genzyme Ireland Limited - January 20, 2026

Genzyme Ireland Limited, a drug product manufacturer in Waterford, Ireland, was inspected by the FDA. The inspection revealed significant deficiencies across multiple areas, including laboratory record keeping, data integrity, quality control procedures, facility maintenance, equipment cleaning, and investigation of discrepancies. These issues indicate a systemic failure to adhere to GMP regulations, potentially impacting product quality and safety.