FDA Mock Inspections and Audits for Medical Device Manufacturers
FDA inspections can come at any time and often with little advance notice. That’s intentional because FDA wants to know that you’re always prepared for an FDA inspection. Are you? Let’s find out. We can help understand the FDA’s quality system inspection technique, determine your state of readiness, and fix what’s broken before the FDA inspector shows up.
How We Help
FDA Mock Inspections
FDAmedix mock audit is a convenient way to test your internal systems and personnel before an FDA inspection. Using FDA’s quality system inspection technique, our auditors will take on the role of FDA inspectors and dig into your processes. We can also share techniques for efficiently organizing FDA audits and managing multiple inspectors. We will:
- Prepare an internal audit plan
- Conduct thorough documentation review, including quality manual and SOPs
- Conduct a mock FDA inspection
- Compile findings and report to management team
- Draft a detailed FDA mock audit report
- Facilitate a remediation planning session to develop your quality transition plan
- Assist with closing gaps revealed in the audit, as desired
Uncover Gaps With a Baseline FDA Audit
Conducted at the start of your quality management system (QMS) implementation or as part of a QMS upgrade, a baseline or gap assessment audit analyzes your current level of compliance to relevant quality standards and/or regulations – including FDA QSR, ISO 13485, MDSAP, EU MDR, and EU IVDR. These audits identify areas of noncompliance and conclude with a formal action plan – the roadmap – for achieving compliance. Because we are a consulting and training company, not a certification or regulatory body, our consultants can provide advice on how to remedy nonconformances.
Private FDA Inspection Readiness Training for Teams
There is an art to effectively managing an inspection. Leveraging decades of experience from our technical experts who have hosted numerous inspections over their careers, Oriel STAT A MATRIX has created a workshop-based training that will show you and your team how to effectively set up a front room/back room audit approach and confidently handle anything an FDA inspector throws at you. Learn more here.
We’re Ready to Help
FDA inspections can be a nerve-wracking experience but less so when you feel confident and prepared. Our team has helped hundreds of medical device companies make sure they are fully prepared for an FDA inspection. Let’s talk about how we may be able to assist your company as well.
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Mock FDA Inspections: Are You Inspection-Ready?
FDA inspections often come without warning—this is by design. The FDA expects your organization to be inspection-ready at all times. Are you?
Let’s evaluate your preparedness. We’ll help you understand the FDA’s quality system inspection methodology, assess your current readiness level, and address any gaps before inspectors arrive.
The primary aim is to uncover potential issues or weaknesses that could surface during an actual inspection—and correct them proactively.
Mock FDA inspections are invaluable tools for identifying deficiencies that could compromise product quality or regulatory compliance.
If your business operates under FDA regulations, it’s essential to know what a mock FDA inspection entails, why it’s important, and how it should be conducted.
Mock FDA Inspection Key Benefits
Gap Identification – Detect compliance weaknesses before they become inspection issues.
Quality System Enhancement – Advance your QMS and processes based on actionable recommendations.
Staff Readiness – Build confidence through interviews, walkthroughs, and inspection drills.
Risk Mitigation – Reduce the chances of receiving FDA Form 483 observations or warnings.
Continuous Improvement Culture – Integrate inspection readiness into daily operations for long-term compliance
Efficient Corrective Action – Use findings to inform CAPA processes, root-cause analyses, and remediation planning.
What a Mock Inspection Typically Includes
Remediation Planning – Define actions, assign responsibilities, and track effectiveness per CAPA requirements.
Facility Walkthrough – Inspect physical conditions, workflows, cleanliness, and organization.
Document Review – Evaluate SOPs, batch records, training logs, CAPA files, and more.
Interviews & Role-Playing – Test staff responses under pressure and identify knowledge gaps.
Simulation of FDA Interactions – Openings, document requests, observations—mimicking a real inspection.
Reporting & Debrief – Summarize findings, deliver prioritized recommendations, and simulate post-inspection response (e.g., Form 483).
We’re Ready to Help
Private FDA Inspection Readiness Training for Teams
Effectively managing an inspection is a skill that requires finesse. Drawing on decades of experience from our technical experts who have conducted numerous inspections throughout their careers, FDAmedix has developed a workshop-based training program. This program will teach you and your team how to successfully implement a front room/back room audit strategy and confidently tackle any challenges presented by an FDA inspector. [MA Note: Provide a link to Training page]
