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Found 3 results for "Genzyme Ireland" across articles, medicines, trials, companies and the glossary

The Anatomy of a Biologics Warning Letter: Deconstructing Genzyme Waterford’s FDA Audit

The Anatomy of a Biologics Warning Letter: Deconstructing Genzyme Waterford’s FDA Audit

The FDA CBER warning letter issued to Genzyme Ireland’s Waterford site in June 2026 is a watershed moment for Irish biopharma. From 11x repeated filter tests to discarded checklists and unexplained deviation cancellations, we analyze the specific CGMP violations and detail what this compliance failure means for quality management across the sector.

Data Integrity and Quality Oversight: Analyzing the FDA Warning Letter for Sanofi's Waterford Site

Regulatory Affairs

Data Integrity and Quality Oversight: Analyzing the FDA Warning Letter for Sanofi's Waterford Site

Following a January 2026 inspection, the FDA has issued a formal warning letter to Genzyme Ireland Limited in Waterford, citing data integrity concerns, uncontrolled checklists, and quality unit oversight gaps in the manufacturing of Thymoglobulin and Altuviiio.

FDA Fires Warning Shot at Sanofi's Irish Plant Over Data Cover-Up and Altuviiio Quality Failings

Regulatory Affairs

FDA Fires Warning Shot at Sanofi's Irish Plant Over Data Cover-Up and Altuviiio Quality Failings

The FDA has issued a formal warning letter to Sanofi's Waterford facility, Genzyme Ireland Limited, citing data integrity breaches, discarded quality records, and botched deviation investigations in the production of haemophilia drug Altuviiio and transplant therapy Thymoglobulin.