Your FDA Inspection Playbook: How to Prepare with Confidence

For MedTech startups, an FDA inspection can be one of the most defining moments in the journey to market. It’s not just about passing an audit — it’s about demonstrating that your organization has established a robust Quality Management System and utilizes its processes to build a device that is safe and effective.

For early-stage teams juggling development, fundraising, clinical planning, vendor management, production transfer, and commercial readiness, inspection readiness often slips to the background until receipt of inspection notice by FDA; at which time it suddenly becomes urgent. That’s when stress spikes, teams scramble, and small gaps can turn into major findings.

Being prepared well in advance allows you to stay calm, organized, and in control of the narrative — instead of reacting under pressure.

This readiness checklist helps founders and quality leaders understand what to expect, where to focus, and how to build a structure that sets the inspection up for success.

FDA Inspection Readiness Checklist

✅ Before the Inspection: Build a Strong Foundation

1. Prepare Your Team

• Identify dedicated staff for supporting the inspection.  This typically includes at a minimum:

  • The primary inspection liaison (usually the management representative)

  • A runner for assisting with document requests, gathering auditees when requested by FDA, etc.

  • A hospitality person to assist with bringing in lunch and refreshments for your team

  • A scribe for taking detailed notes and keeping up with records requests

• Ensure that every team member understands their role during the inspection and is familiar with the quality policy or its location.

• Train staff on how to answer questions clearly and succinctly.

• Develop a list of Subject Matter Experts (SMEs) and confirm that each SME is familiar with their subsystem and relevant documents.

• Notify critical suppliers (CMO, sterilizer, etc.) of the upcoming inspection in the event FDA requests records from their systems.

2. Organize Key Documents & Records

• Prepare a current copy of the org chart, ensuring that the management representative role is identified.

• Review and update the quality manual as necessary to ensure it reflects the current state of the QMS.

• Create a master list of documents, records, and logs likely to be requested.  This typically includes:

  • CAPAs

  • Complaints and MDRs

  • Document/engineering change records

  • Nonconformance reports

  • Receiving inspection logs

  • Equipment logs

  • Calibration and maintenance logs

  • Recalls (including recall decisions)

  • Purchase orders, sales orders, and inventory records

  • Approved supplier list and supplier evaluation records

• Confirm that all documents are controlled, approved, versioned, and current.

• Make sure that all training is current and records are accessible.

• Prepare digital or physical copies for fast and organized retrieval.

3. Close Known Gaps Early

• Correct gaps where possible before the inspection. Self-identification and acknowledgement of issues via documentation in the CAPA system is much preferable to gambling on the FDA not identifying the problem. It can make the difference between that deficiency becoming a finding or not. 

• Since customer complaints and CAPAs are prioritized during every inspection, they should be up to date to the extent possible. If these records remain open for an extended period, the most current status should be included in the record to show due diligence. 

4. Set Up the Right Environment

• Prepare a clean, professional “front room” where the inspection will be conducted.

• Designate a “back room” for document request compilation, internal coordination and document review for prepping SMEs.

• Align on hospitality basics and ensure communication flow is clear.

• Ensure that the facility is clean and tidy, pest control is up to date, and that product is stored, handled and identified per defined requirements.

• Verify that the calibration status of all equipment is current and labeled.

• Verify that any printed documentation is the current, released version.

• Remove any post it notes or other notes that represent tribal knowledge.

5. Plan the Opening Meeting

• Invite top management and SMEs to demonstrate the organization’s commitment to the inspection process.

• Introduce key personnel and explain your company succinctly.  A brief presentation about the product or a product demonstration may be offered as a courtesy. 

• Set a tone of transparency, professionalism, and readiness.

6. Manage Document Flow

• Route and log all requests through one liaison to ensure prompt fulfillment.

• Review documents internally before presenting them to the inspector.

7. Prepare SMEs Before They Speak

• Provide context for the inspector’s questions where relevant.

• Ensure SMEs know what documents have been requested and previously presented.

• Coach them to stick to facts — no guessing, no speculation, and refer to procedures when required.

• Answer truthfully and directly, without unnecessary detail.

• If unsure, request time to confirm information, check procedures, etc.

• Maintain a calm, collaborative tone throughout.

8. Take Detailed Notes

• Document all inspector questions, feedback, and reactions.

• Note potential findings in real time.

• Capture commitments or follow-up actions.

After the Inspection: Respond with Precision

9. Initiate CAPAs Promptly

• Initiate corrective and preventive actions immediately for all findings.

• Perform root cause investigations thoroughly.

• Implement actions in a timely manner.

10. Build a Strong Response Package

• Submit a clear, well-evidenced written response.

• Include timelines and corrective action plans.

• Add verification-of-effectiveness plans for each CAPA.

11. Keep Improving

• Treat the inspection as a learning opportunity.

• Conduct a post-mortem to determine what went well and what should be improved on for the next Inspection. 

Why Preparation Matters

For startups, the stakes in an FDA inspection are uniquely high. Poor inspection results can derail timelines, strain resources, or create Investor concerns. Preparation isn’t just about passing an inspection — it’s about protecting your momentum.

That’s why many founders lean on expert partners to guide them through the process.

We support startups at every stage of inspection readiness: helping teams understand expectations, close gaps early, manage document flow, prepare SMEs, and navigate sensitive moments with confidence. We’ve supported inspections across a wide range of device types and stages, and we understand how to ensure startup teams feel calm, organized, and in control.

With the right preparation — and the right support — your inspection becomes not a source of anxiety, but a milestone that validates the strength of your quality system and accelerates your path to market.

Contact us today to learn more.