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A Global Milestone for Wellness: Chanelle McCoy Health Secures Historic Dual SFDA and European Novel Food Regulatory Approvals ◆ The Digital and Regulatory Frontier: Top 10 Technical and GMP Trends Shaping Pharma in 2026 ◆ Funding the Future: Inside the €75k Women TechEU and £10M Createch Grants for Startups and SMEs ◆ FDA Fires Warning Shot at Sanofi's Irish Plant Over Data Cover-Up and Altuviiio Quality Failings ◆ Top Universities in Ireland: Discover the Country's Leading Higher Education Institutions ◆ The Irish Startup Ecosystem: A Comprehensive Funding and Development Guide for Entrepreneurs ◆ A Global Milestone for Wellness: Chanelle McCoy Health Secures Historic Dual SFDA and European Novel Food Regulatory Approvals ◆ The Digital and Regulatory Frontier: Top 10 Technical and GMP Trends Shaping Pharma in 2026 ◆ Funding the Future: Inside the €75k Women TechEU and £10M Createch Grants for Startups and SMEs ◆ FDA Fires Warning Shot at Sanofi's Irish Plant Over Data Cover-Up and Altuviiio Quality Failings ◆ Top Universities in Ireland: Discover the Country's Leading Higher Education Institutions ◆ The Irish Startup Ecosystem: A Comprehensive Funding and Development Guide for Entrepreneurs ◆

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Found 2 results for "Altuviiio"

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

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

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.