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FDA Finds Gaps in Genzyme’s Data Integrity Program; Warning Letter Cites Discarded Review Records

The FDA has issued a warning letter to Sanofi’s Genzyme manufacturing facility in Waterford, Ireland, after identifying significant weaknesses in Data Integrity and quality management during an inspection. The agency found deficiencies in laboratory record reviews, traceability, and deviation handling
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FDA Finds Gaps in Genzyme's Data Integrity Program; Warning Letter Cites Discarded Review Records

Novo Nordisk Faces FDA Warning Letter — Missed Death Reports Expose Pharmacovigilance Failure

FDA issues warning letter to Novo Nordisk over missing safety reports and death data gaps in pharmacovigilance systems, citing serious compliance breakdowns and increasing inspection risk.
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Pharmacovigilance specialist analyzing drug safety data and regulatory reports in a digital pharmaceutical monitoring system with AI-driven risk visualization dashboards.