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Found 3 results for "CBER" across articles, medicines, trials, companies and the glossary
Pharmaceutical
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.
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.
Pharmaceutical
How the Iran Conflict Is Disrupting Ireland’s Pharmaceutical Industry and Why It Matters Globally.
Middle East air route disruptions are raising costs and delaying Ireland’s pharma exports, impacting global medicine supply chains.