Tag: CAPA Plan

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fda-warning-letter-analysis

FDA Warning Letter Analysis: Catalent Indiana, LLC

This FDA Warning Letter analysis examines how weak investigations, ineffective contamination control strategies, and batch-release-driven decision making allowed contamination risks...
fda-warning-letter-analysis

FDA Warning Letter Issued to Rhyz Analytical Labs – November 12, 2025

FDA Warning Letter to Rhyz Analytical Labs cites CGMP failures in OOS investigations and Quality Unit oversight at a contract...
fda-warning-letter-analysis

FDA Highlights Systemic Issues at Mylan Laboratories in Recent Warning

FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to...
fda-warning-letter-analysis

FDA Warning Letter: MedOffice Saglik Endustri Anonim Sirketi

he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer...
Corrective and Preventive Actions (CAPA) Plan in GMP

Corrective and Prevention Action (CAPA) Plan in GMP

Explore CAPA's role in GMP for pharmaceuticals: key processes, challenges, and strategies for regulatory compliance...

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