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Auditing and FDA Inspection Preparation

EAS Consulting Group offers comprehensive auditing services, from desk-reviews of documents, policies, and procedures to in-depth mock-FDA inspections for firms of all sizes, including FSMA Readiness Assessments. These audits provide pertinent details of both strength and weaknesses within a firm and further the ability to meet all FDA expectations.

EAS auditors are former FDA, USDA and state investigators, laboratory personnel and industry quality experts who conduct GMP/Quality Systems audits of suppliers, contract manufacturing and laboratory facilities to assess compliance with applicable FDA state regulatory requirements as well as established best practices. We conduct gap assessments of these facilities to let you know what improvements are needed to become fully compliant with FDA state requirements. Our assessments are thorough and complete. You will receive a detailed report outlining your current level of compliance with each section of the GMP rule, with our recommendation as to what needs to be done to bring identified deficiencies into compliance.

Desk Audits

“Mock-FDA” Inspections

Open Communication Gap Analysis

Private Third-Party Auditing (GSFI)

Each audit includes a detailed report listing all of the observations found as well as Corrective and Preventive Action Recommendations.

  • Domestic and Foreign GMP Audits (GMP)
    – Onsite
    – Contractor Manufacturer
    – Packing
    – Distribution
    – Laboratory Facilities
  • Food Safety Modernization Act (FSMA)
  • Foreign Supplier Verification Programs (FSVP)
  • ISO-based Quality Systems
  • Good Agricultural Practices (GAP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices (GCP)
  • Good Documentation Practices (GDP)
  • Hazard Analysis and Critical Control Points (HACCP)
  • Low-Acid Canned Food (LACF)
  • Review Standard Operating Procedures
  • Marketing and Social Media Statements
  • Verification of Supply Chain Management
  • Quality System Regulation Audits
  • EU/ISO13485 GMP Assessments

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