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Found 4 results for "Waterford"
Regulatory
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.
Regulatory
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.
News
Leading CDMO Companies in Ireland: Your Complete Guide to Contract Manufacturing in 2026
A comprehensive guide to the top CDMO companies in Ireland - from Hovione and Thermo Fisher in Cork to EirGen Pharma in Waterford and HiTech Health in Galway. Full profiles, capabilities, certifications, and facilities of Ireland's leading contract development and manufacturing organizations.
News & Insights
How to Get Your First Pharma Job in Ireland in 2026: The Complete Step-by-Step Guide
A practical, no-nonsense guide for science graduates and career changers looking to break into Ireland's world-class pharmaceutical and MedTech sector in 2026.