Mock FDA Inspections & Audit Preparation

Be Ready Before the FDA Arrives

Whether you're manufacturing drugs, medical devices, nutraceuticals, or importing FDA-regulated products, routine FDA inspections are required by law—and they can happen with or without warning.

If you're new to the industry or launching a new product line, you're even more likely to be inspected. That’s where we come in.

Our Mock FDA Inspection & Audit Prep Services

We help you get inspection-ready with realistic mock audits, expert guidance, and compliance strategies based on FDA’s Investigations Operations Manual (IOM). Our team ensures your facility, systems, and documentation are fully prepared—reducing the risk of 483s, warning letters, or costly delays.

We focus on the key areas the FDA reviews:
✅ Pre-Inspection Readiness – What to expect, how to engage with inspectors, and how to manage documentation and team response.
✅ Facility Walkthroughs – Simulated inspections that mirror FDA protocols.
✅ Documentation Review – We evaluate your Quality Management System, SOPs, CAPA procedures, risk analysis, and training programs.
✅ Audit Coaching – We train your team on how to communicate with inspectors, manage observations, and present corrective actions.
✅ Closeout Meeting Prep – Guidance for handling findings, explaining improvements, and responding appropriately.
✅ Post-Inspection Support – Help with your FDA 483 response strategy, timelines, and corrective action documentation.

Want peace of mind before your next inspection?
Let’s schedule a mock audit and make sure you're fully prepared.
👉 Contact us today to get started.