FDA Inspection Audit Support

Inspection Readiness. Audit and preparedness. Product, systems, and facility qualification and validation.

FDA Audit Support Services
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GxP Audit Support

Our team of FDA experts understands the importance of a successful inspection, and the role that a detailed audit can play in your inspection outcome.

We know the importance of fostering a culture of quality and establishing a proactive quality management system.

Whether you are in need of a comprehensive corporate quality management system audit or a completely focused site audit, our thorough, highly-effective, attentive and scalable FDA audit support services help you reduce FDA inspection risks while you continue to focus on your business objectives.

Validation / Qualification Activities:

  • Evaluation of products, equipment, and facilities
  • Qualification of policies, procedures, protocols, and master plans
  • Computer Systems Validation and 21CFR Part 11 Compliance
  • Validation of:
    • Manufacturing, labelling, and packaging processes
    • Cleaning and sterilization systems and processes
Validation & Qualification
FDA Inspection

Other Inspection Related Activities:

  • Internal audits or GAP assessments of the Quality Management System
  • Vendor and Supplier audits
  • GDP audits
  • Due Diligence

Audits Include the Following Customizable Components

  • A pre-audit kickoff call outlining client objectives and daily agenda for the audit, including customized audit approach:

    • Formal FDA Audit, “Hats-on, Hats-off” Audit, deep dive into specific area, high level “checkup”, etc.
  • Onsite or remote audit with guidance before and during the inspection
  • An initial summary of the overall audit findings at the close of the onsite visit
  • A detailed, written audit report outlining Observations & Deficiencies (categorizing by criticality)
  • A risk-based Corrective Action Plan (Premier FDA Solutions can also assist with any needed post-audit remediation of documents and Quality System GAPs.)


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