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Mock FDA Inspections

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Mock FDA Inspections: A Proactive Tool for Compliance Success

Don’t wait for the FDA to uncover your weaknesses—find and fix them now.

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For most life science companies that are subject to FDA regulation, it is essential that you are always ready for an FDA inspection. FDA inspections can result from clinical studies, prior to regulatory approval, or as part of oversight of commercial manufacturing of FDA-regulated products. Be clear – the stakes for FDA inspection outcomes couldn’t be higher. A single FDA inspection can result in multiple observations on an FDA 483, warning letters, or even operational shutdowns if significant compliance gaps are identified. At Compliance Architects®, we understand the importance of being inspection-ready at all times. That’s why we offer comprehensive mock FDA inspections, designed to simulate real FDA interactions and prepare your organization for regulatory scrutiny.

 

A Realistic Dry Run—Without the Risk

What Are Mock FDA Inspections?

Mock FDA inspections are carefully designed exercises that replicate the process, rigor, and scope of actual FDA inspections. These simulations allow companies to assess their compliance with FDA regulations – from the perspective of an FDA Investigator, and experience the stress and demands that an actual FDA inspection will place on our organization. A mock FDA inspection will also help you identify potential compliance deficiencies, and develop strategies to mitigate risks (and get ready!) before facing an actual inspection. Mock inspections are particularly valuable for pharmaceutical, biotechnology, medical device, food, dietary supplement, and cosmetic manufacturers. 

At Compliance Architects, we bring decades of hands-on FDA and industry experience to conduct mock inspections with rigor and precision. Generally, we recommend mock inspections be performed by our best-in-class ex-FDA Investigators. These experts have served in FDA Investigator roles across regulated industries and understand exactly what FDA Investigators look for during inspections. This allows us to deliver realistic and impactful mock inspection experiences.

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What to Expect From Our Mock Inspections

Key Components of Mock FDA Inspection

Realistic Simulation of FDA Inspection Practice: Our mock FDA inspections are designed to mirror real FDA inspections as closely as possible and includes (but is not limited to):

  • Conducting opening meetings to outline the inspection scope.
  • Conducting an initial probing walkthrough of your facility or operation.
  • Requesting and reviewing quality documentation and quality records, including but not limited to standard operating procedures (SOPs), distribution records, batch records, laboratory methods, lab notebooks, product release documentation and training logs.
  • Observing individual process steps on the manufacturing floor or within laboratory settings.
  • Reviewing non-conformances, deviations and CAPAs for rigor and process adherence.
  • Conducting in-depth interviews with staff to evaluate their understanding of regulatory requirements and their ability to support inspection with subject matter expertise.
  • Stressing your company’s ability to handle an aggressive inspection.

Comprehensive Compliance Assessment: We evaluate your organization’s compliance with applicable FDA regulations, including:

  • Good Manufacturing Practices (GMP) For manufacturing facilities.
  • Good Clinical Practices (GCP): For clinical research organizations.
  • Good Laboratory Practices (GLP): For laboratories.
  • Along with all other particular regulatory standards, requirements and guidances related to your operation. These can be product-specific, regulated product class specific, or flow from FDA reliance on ISO or ICH documents or standards.

Gap Analysis and Risk Assessment: A key deliverable of our mock inspections is a comprehensive gap analysis. This detailed report identifies:

  • Areas of poor mock inspection performance and corresponding regulatory risk.
  • Inspection process inefficiencies or gaps in documentation after making requests.
  • Organizational vulnerabilities that could lead to adverse inspection outcomes.

Customized Recommendations: Following the mock inspection, we provide actionable recommendations to help your organization address deficiencies and strengthen its readiness for an FDA inspection. Our team works with you to prioritize these recommendations based on risk and operational impact.

FDA Form 483 Simulation: At the end of the mock inspection, we will issue simulated FDA Form 483 observations. This allows your team to experience the process of receiving and responding to an Investigator about the observations in a controlled environment. We also provide guidance on how to craft effective, regulator-friendly responses.

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From Simulation to Strategy

Why Your Organization Needs a Mock FDA Inspection

  • Proactive Risk Mitigation: Even with a recent prior FDA inspection, assuming your organization is ready for an FDA inspection is a gamble. FDA Investigators change. Your company changes. Personnel change. Mock inspections allow you to identify and address risks regularly, and before they become significant compliance risk problems.
  • Regulatory Confidence: By simulating the inspection experience, your organization will gain confidence in its inspection readiness and be able to apply those readiness learnings to day-to-day work operations.
  • Employee Preparedness: FDA inspections can be stressful for employees. Mock inspections provide an opportunity to train staff, familiarize them with the inspection process, and prepare them to respond confidently to inspector questions.
  • Continuous Improvement: The insights gained from a mock inspection go beyond immediate risk mitigation needs. Mock inspection insights can form the basis for improvements in quality systems, operational efficiency, and overall regulatory strategy.
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An Insider’s View of the FDA—On Your Side

Why Choose Compliance Architects?

At Compliance Architects, we pride ourselves on delivering mock FDA inspections that go beyond a superficial exercise. Our approach is rooted in:

  • Unmatched Expertise: Our team includes former FDA officials, seasoned quality professionals, and industry veterans with extensive regulatory knowledge.
  • Tailored Solutions: We understand that every organization is unique. Our mock inspections are customized to align with your specific operations, products, and regulatory challenges.
  • Actionable Results: We don’t just point out problems – we provide practical, detailed recommendations that empower your organization to achieve sustained compliance.
  • End-to-End Support: From conducting the mock inspection to implementing corrective actions and preparing for the next steps, Compliance Architects supports you every step of the way
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What to Expect from a Mock FDA Inspection with Compliance Architects

When you partner with us for a mock FDA inspection, you can expect:

  • Thorough Pre-Inspection Communications: We start by working with your current staff and operational leadership to ensure they understand the objectives of the mock inspection, and to help prepare the organization for the exercise. We also gather similar preliminary information that FDA might request prior to an actual inspection. The objectives are to make sure the mock inspection exercise meets your company objectives for readiness and risk mitigation.
  • A Realistic Inspection Experience: Our team conducts the mock inspection onsite, and in a way that mimics an FDA Investigator’s approach – including walkthroughs, targeted interviews, and document requests.
  • A Detailed Post-Inspection Report: After the mock inspection, we provide a comprehensive report detailing our findings, risk assessments, and prioritized recommendations for improvement.
  • Training and Follow-Up: We offer training sessions to help your team understand the inspection findings and implement improvement actions effectively. Our experts are also available to help your team prepare for any upcoming FDA inspections.

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Let Compliance Architects simulate the pressure of a real FDA inspection—so your team can learn, improve, and be ready when it counts.

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