FAQs
Inspection Readiness & Quality Systems
Q9: What are the most common causes of FDA 483 observations for IVD companies?
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The specific gaps that recur most frequently include the following:
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Design inputs that are too vague to verify objectively
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Design outputs not formally linked to design inputs in the DHF
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Verification test reports that don't reference the specific protocol executed or lack underlying data
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Design changes made during development that were never put through formal change control
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Labeling not maintained as a design output with documented traceability.
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Risk management file deficiencies are the second most common category — specifically, risk controls that exist in the risk management file but can't be traced to corresponding design outputs and verification evidence.
Under QMSR, FDA now explicitly looks for integration between the risk management file and the DHF rather than treating them as separate submissions.
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Customer complaints, CAPA system deficiencies, and supplier control gaps round out the most frequently cited observation categories. Landrich Group's DHF Traceability Scan is designed to readily identify these gaps before an inspector opens the file.
The Landrich Group has certified lead auditors to perform QMS Gap Analysis relative to QMSR/ISO 1385:2016 requirements and perform mock audits of DHFs and electronic Trial Master Files (eTMFs) to ensure FDA and other National Competent Authority (NCA) inspection readiness.
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