FAQs
Inspection Readiness & Quality Systems

Q10: What is a mock FDA audit and when should we schedule one?

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A mock FDA audit is a structured independent review that simulates the FDA inspection experience from an independent third-party auditor. In this exercise, an external reviewer evaluates your Quality Management System, Design History File (DHF), electronic Trial Master File (eTMF), and supporting documentation the way an FDA investigator would. The reviewer uses the same Compliance Policy Guide and other established auditing frameworks to simulate an FDA or BIMO inspection.  Program framework and traceability chains without the benefit of socialization, tribal knowledge, and organizational memory.

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The most important word in that description is 'independent.' Internal audits are valuable for ongoing quality maintenance, but internal reviewers have too much context to reliably find the gaps an external inspector will catch. 

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The right time to schedule a mock audit is 4–6 months before an anticipated FDA inspection or submission. Class III Pre-Market Approval (PMA) devices typically have a Pre-Approval inspection as the FDA completes its substantive review It is important to allow sufficient time to address significant findings before the real event. Landrich Group conducts mock FDA inspections for IVD, CDx, and medical device companies as a structured 2–3-week engagement.

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The Landrich Group has ISO 13485:2016 and ISO 9001:2015 Certified Lead Auditors to conduct mock audits and has developed a proprietary Audit Findings Tracker for systematically identifying potential audit observations.  As an output of the mock audit, clients are routinely provided with recommended corrections, corrective and preventive actions, and continuous process improvements to provide a high degree of confidence with any planned or unplanned inspections.  Depending on the size and scope of studies and QMS, a mock audit could be completed in 1-2 months.   

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