FDA WARNING_LETTER - Genzyme Ireland Limited - January 20, 2026

The United States Food and Drug Administration (FDA) issued a warning letter to Genzyme Ireland Limited following an inspection of its Waterford facility from January 12 to January 20, 2026. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) standards, rendering the biological products Thymoglobulin and Altuviiio adulterated under the Federal Food, Drug, and Cosmetic Act. The primary concern involves the failure of the company’s quality control unit to provide adequate oversight. Specific issues include widespread data integrity failures, such as failing to document repeated test failures and particulate excursions. Environmental monitoring records were found to be unreliable, as documented sampling times did not align with personnel access logs. Furthermore, the firm utilized unofficial checklists that were discarded and failed to properly investigate unexplained discrepancies, frequently canceling deviation reports without determining root causes or assessing the impact on product quality. The FDA noted that while Genzyme proposed some corrections, they failed to address the systemic nature of these quality failures. The agency requires Genzyme to submit a written response within 15 working days. This response must include a comprehensive assessment of data integrity across all operations, an expanded retrospective review of canceled deviations, and a revised investigation into unidentified residues found in manufacturing equipment. Failure to resolve these issues may lead to legal actions, such as product seizures or injunctions.