FAQs
Inspection Readiness & Quality Systems

Q6: How do I prepare for an FDA inspection as an IVD manufacturer?

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As an IVD manufacturer, your quality assurance systems are a primary focus when preparing for an FDA inspection. The FDA transitioned to a new Compliance Program, 7382.850, in 2026. Under the new inspection model, the regulatory agency will expect your quality functions to be a coherent, documented, traceable system.

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Preparation for an anticipated inspection should begin at least 4-6 months in advance. The scope should include four areas. The first is Design History File (DHF) traceability, which confirms every design input maps to an output, verification evidence, and a change control record. The second is risk management file integration with the DHF. The last two areas are supplier oversight documentation and management review records. These four domains are explicitly listed in scope for FDA investigators under the current Quality Management Systems Regulation (QMSR).

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The most effective preparation tool is a structured mock audit. In this exercise, an independent reviewer approaches your documentation with the same approach as an FDA investigator. The reviewer follows the traceability chain without the benefit of organizational memory, thereby exposing gaps that are easy for an internal team to overlook. Landrich Group conducts mock FDA inspections for IVD and device companies as a standalone service.