Prepare IVD manufacturing, reagent, labeling, and quality-system records for an FDA inspection with a review scoped to the actual product and operation.
Focus the review on your diagnostic product
An IVD inspection-readiness engagement can examine how intended use, product requirements, manufacturing evidence, labeling, complaints, and corrective actions connect. The appropriate scope depends on the device, activities performed, applicable requirements, and the situation prompting the review.
Areas to discuss
- QMSR readiness and quality-system record retrieval.
- Reagent and kit lot traceability.
- Labeling, instructions, and supported claims.
- Supplier and outsourced-process controls.
- Complaint investigations and corrective-action evidence.
- Mock inspection interviews and document-request practice.
Read the IVD guidance cluster
- IVD inspection preparation under the current framework
- Reagent lot traceability
- RUO labels and intended use
- Internal audit and management-review records
Choose the situation that needs support
Request an IVD readiness review before an inspection, or discuss an upcoming inspection or FDA Form 483. We can discuss remote document review, on-site support, and the deliverables appropriate to the engagement. Agree scope, consultant fit, and next steps before work begins.
Related inspection resources
Primary sources
Sources reviewed October 20, 2026. The preparation steps above are practical suggestions; the linked regulations and FDA documents define the applicable requirements.
Discuss inspection readiness or response support