Summary

• FDA inspections are common and expected — over 600 take place annually across sponsors, CROs, and sites.
• Inspectors focus on protocol adherence, data integrity, consent processes, and documentation.
• Sponsors must show how they selected and monitored sites (including site feasibility, performance metrics, and oversight).
• Sites must be ready with complete, accurate, and timely source data, training logs, delegation records, and AE documentation.
• Inspection readiness should start at study initiation, not after the notification — with strong documentation, team training, and SOPs.
• Sponsor-site communication is key to successful inspection outcomes and reducing findings.
• During the inspection: stay calm, assign a point of contact, answer clearly, and provide documents promptly.
• Intune Bio helps sponsors find verified, inspection-ready sites and track documentation and performance across a global trial network.

If you work in clinical research, you know this moment all too well: the email or phone call that says,

“You’ve been selected for an FDA inspection.”

Even if you’ve done everything right — documented every visit, trained every staff member, and filed every deviation — there’s still a moment of panic. What will they ask for? What if they show up tomorrow? What if we miss something?

Take a breath. You’re not alone — and you’re not powerless.

Whether you’re a trial sponsor overseeing a network of global sites or a site coordinator preparing your first inspection, this guide gives you a grounded, real-world approach to FDA inspection readiness — drawn from field experience, best practices, and regulatory guidance.

Why FDA Inspections Still Matter

Even in 2025, FDA inspections remain a critical part of the regulatory oversight process.

They’re used to:

• Confirm Good Clinical Practice (GCP) compliance
• Validate data integrity
• Ensure human subject protection
• Evaluate site conduct, training, and documentation
  

The FDA conducts over 600 bioresearch monitoring inspections annually, focusing on clinical investigators, sponsors, CROs, and IRBs [1].

If you’re part of a global clinical trial network, inspection preparedness isn’t optional — it’s a shared responsibility.

Step 1: Know What the FDA Will Ask For

FDA inspectors don’t operate from mystery checklists. Their inspections follow defined protocols, often outlined in Form FDA 483 when findings are noted.

Here’s what they’ll typically request:

• Essential documents: Protocols, ICFs, training logs, delegation logs, CVs
• Source data: Charts, labs, EDC entries, AE reports
• Monitoring reports and communications
• Drug/device accountability records
• Deviation logs and CAPA plans
  

If you’re the sponsor, be prepared to provide:

• Clinical trial site selection rationale
• Documentation from your clinical trial site database
• Details on how site feasibility was assessed and how performance was tracked
  

If you’re a site, expect inspectors to verify:

• That you followed the protocol
• That all data is traceable and timely
• That informed consent was appropriately handled

Step 2: Create a Culture of Inspection Readiness

FDA inspections don’t start with a knock on the door — they start the day the trial begins.

High-performing teams (and sites) build inspection readiness into their daily workflows, including:

• Training staff on GCP and protocol-specific requirements
• Conducting internal mock audits
• Keeping documentation up-to-date — not just at closeout
  

This isn’t just compliance — it’s good science. It ensures clean data, ethical conduct, and sponsor-site alignment.

As one seasoned coordinator put it:

“We prepare for inspection by treating every day like it could be one.”

Step 3: Build Relationships that Support Inspection Readiness

Strong sponsor-site communication is key. Sponsors should support sites with:

• Clear startup packets (including inspection prep tips)
• Shared documentation portals
• Centralized SOPs and real-time issue resolution
  

Sites, in turn, should feel empowered to ask for help — whether it’s clarifying a protocol requirement or responding to a monitoring query.

When sponsors and sites collaborate transparently, FDA findings decrease and inspection outcomes improve [2].

Step 4: During the Inspection — Stay Calm, Stay Clear

The day has come. Here’s how to handle it:

• Greet the inspector professionally
• Assign a point of contact (e.g., site director or QA lead)
• Provide requested documents promptly
• Answer questions factually and succinctly
• Never guess — it’s okay to say, “Let me confirm that for you.”

And sponsors — stay close. If your sites are inspected, be ready to support them with documents, clarifications, or direct engagement.

Final Tip: Don’t Wait for the Knock

Whether you’re figuring out how to find clinical trial sites, running feasibility, or preparing for submission, regulatory readiness should be built into every trial phase.

At Intune Bio, we help sponsors:

• Match with verified, inspection-ready clinical sites
• Use tools to streamline clinical trial site selection
• Track performance and documentation across a global clinical trial network
• Improve clinical trial site feasibility decisions with real data

Ready to Improve Your Inspection Readiness?

We built Intune to give trial teams a smarter way to prepare, monitor, and move forward — without being caught off guard.

Explore our clinical site dashboards

See how automated matching for clinical trial sites saves time and reduces risk

Schedule a demo to see it in action

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Sources:

[1] FDA Bioresearch Monitoring Program. FDA.gov

[2] TransCelerate. Improving Sponsor-Site Collaboration to Improve Inspection Outcomes.

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