Case Study: Remediation Project – Massachusetts


Learn how The FDA Group has been working closely with a large healthcare Company to overcome a variety of compliance-related issues through comprehensive remediation, quality systems audits, extensive record review, ongoing CAPA improvements, new complaint handling protocols and updated Standard Operating Procedures.

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Case Study: International Auditing Project


Learn how The FDA Group supported a large healthcare Company’s Quality & Regulatory Audit Project, uncovering significant quality issues and utilizing its staff of former FDA personnel to conduct specialized audits pertaining to Warning Letters and other high profile situations while empowering the Company to improve internal auditing procedures, quality system management and record review processes.

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Case Study: Remediation Project – Ohio


Learn how The FDA Group planned and executed a comprehensive remediation project in response to Warning Letters issued to a large healthcare Company, integrating improvements into the Company’s Standard Operating Procedures while training staff in accordance with FDA expectations and monitoring the effectiveness of those improvements over time.

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