Attending an FDA Inspection: Lessons from a Zero-Observation Success

This week, I had the privilege of attending an FDA inspection at a medical device company. After three months of meticulous preparation following the inspection announcement in December, we successfully concluded the inspection with zero observations (NAI: No Action Indicated). I would like to share the key success factors that contributed to this outcome.

Key Success Factors

1. Executive Leadership Presence
The company president and executives personally greeted the inspector at the beginning of the inspection. This demonstrates that top management has established the quality system and maintains control over employees—a critical aspect in FDA’s eyes. While Japanese organizations often tend toward a bottom-up approach, Western regulatory expectations favor clear top-down management structures. This alignment with international norms is particularly important as FDA transitions to the Quality Management System Regulation (QMSR), which formally incorporates ISO 13485:2016 and emphasizes “top management” responsibilities effective February 2, 2026.

2. Commitment to Honesty and Integrity
The president explicitly committed to answering all questions honestly and with integrity. The United States places great emphasis on justice and transparency. Dishonesty, fraud, and excuses are strictly prohibited and can lead to severe consequences. FDA inspectors are trained to identify inconsistencies and value candor above all else.

3. Maximum Cooperation Pledge
The president conveyed our commitment to providing maximum cooperation to the inspector. This establishes a collaborative rather than adversarial tone for the inspection.

4. Comprehensive Mock Inspection Rehearsals
We created anticipated question-and-answer documents and conducted multiple mock inspection rehearsals. This preparation enabled our team to respond confidently and consistently during the actual inspection. In 2025, FDA inspections have become more data-driven and targeted, making thorough preparation even more essential.

5. Rigorous Internal Auditing Program
We conducted comprehensive internal audits, identifying even minor issues and implementing corrective and preventive actions (CAPA) before the inspection. When a company proactively identifies and resolves issues through internal audits, there are fewer findings for FDA inspectors to cite. This risk-based approach to quality management aligns with the emphasis in ISO 13485:2016 on risk management and proactive quality improvement.

6. Clear Process Flow Documentation in English
Since explaining procedures directly from Japanese Standard Operating Procedures (SOPs) could lead to misunderstandings, we created English process flow diagrams. These visual representations provided clear, concise explanations of our procedures before detailed discussions, facilitating better communication and reducing the risk of misinterpretation.

7. Electronic Document Retrieval System
We utilized electronic systems to quickly search and present SOPs and records. Notably, the inspector did not question our Computer System Validation (CSV) practices or 21 CFR Part 11 compliance for this document management system. This experience reinforces an important principle: CSV and Part 11 compliance are critical for systems that handle raw data directly affecting medical device safety, effectiveness, and quality. However, using computer systems for document retrieval and presentation during inspections does not automatically trigger extensive Part 11 compliance requirements. The inspector’s priority is efficient access to information, preferring electronic retrieval over waiting for manual paper searches. That said, organizations should maintain appropriate controls for electronic records used in GMP-regulated activities, including audit trails for critical quality records and validated systems where required by risk assessment.

8. Efficient Paper Document Management
For paper-based materials, we conducted repeated training sessions on document retrieval procedures, ensuring our team could quickly locate and present appropriate documents. Time is valuable during inspections, and efficient document management demonstrates organizational competence.

9. Professional Respect for the Inspector
We treated the inspector with appropriate professional respect throughout the process. Inspectors are regulatory professionals performing an important public health function, and respectful treatment facilitates productive dialogue.

10. Thoughtful Hospitality
We provided thoughtful hospitality to the inspector. This is actually quite significant. Inspectors are human beings who often travel to foreign countries where they may face language barriers, time zone challenges, and unfamiliar environments. During my career, I have observed that treating inspectors as valued professional guests—attending to their comfort regarding meals, accommodations, and even room temperature—creates a positive atmosphere that facilitates constructive communication.

Understanding the Inspector’s Perspective

FDA inspections represent one week of continuous tension and pressure, but it is important to remember that inspectors also experience stress during this period. Inspectors are not adversaries; they are regulatory professionals with an important mission to protect public health. I have occasionally heard companies refer to their document storage room during inspections as a “War Room,” which reflects an unfortunate adversarial mindset that is not productive.

As we approach the implementation of QMSR in February 2026, medical device manufacturers must recognize that FDA’s inspection strategy has evolved. The agency’s approach in 2025 has become smarter, faster, and more interconnected. FDA continues to issue warning letters at a rate consistent with the elevated pace set in 2024, marking a significant increase over prior years even with an overall decrease in the number of inspections over the past decade.

Current Regulatory Landscape (2025-2026)

Medical device manufacturers should be aware of several critical regulatory developments:

Quality Management System Regulation (QMSR): The FDA finalized the QMSR on February 2, 2024, which will replace 21 CFR Part 820 (QSR) effective February 2, 2026. This regulation formally incorporates ISO 13485:2016 by reference, representing a significant harmonization with international standards. Manufacturers should begin transitioning now, reviewing documentation, updating procedures, and ensuring their QMS reflects both FDA and international expectations.

Enhanced Enforcement Focus: FDA’s 2025 enforcement activities have intensified after a relatively quiet January. As of early September 2025, FDA had issued 19 warning letters citing QSR violations—already surpassing the total for the same period in 2024. Areas of particular focus include contract manufacturer oversight, data integrity, and systemic compliance gaps.

Risk-Based Approach: The integration of ISO 13485:2016 emphasizes risk-based decision making throughout the product lifecycle. Organizations must demonstrate not just compliance documentation, but competent risk management practices embedded in their quality systems.

AI and Emerging Technologies: FDA issued new guidance in January 2025 on Artificial Intelligence-Enabled Device Software Functions, addressing lifecycle management and marketing submission recommendations. Organizations developing AI-enabled devices must incorporate these considerations into their quality systems.

Inspection Readiness Classification

Following an FDA inspection, the agency classifies the inspection outcome into one of three categories:

No Action Indicated (NAI): No significant issues were identified. This is the ideal outcome we achieved.

Voluntary Action Indicated (VAI): Observations were made, but they do not require formal enforcement action. The company is expected to address these voluntarily.

Official Action Indicated (OAI): Significant issues were identified that may lead to warning letters, consent decrees, or other regulatory actions.

All FDA inspection reports, Form 483 observations, and warning letters are publicly available on the FDA website, making transparency and compliance essential not just for regulatory reasons, but also for maintaining market reputation.

Best Practices for Modern FDA Inspection Readiness

Successful FDA inspection readiness in 2025-2026 requires more than a checklist approach—it demands a strategic capability embedded in organizational culture:

1. Align with International Standards: Ensure your QMS reflects ISO 13485:2016 requirements in advance of the February 2026 QMSR implementation. This provides smoother global market access while meeting FDA expectations.

2. Implement Risk-Based Quality Management: Move beyond simple compliance documentation to demonstrate risk-based decision making throughout design, manufacturing, and post-market activities.

3. Strengthen Oversight Systems: Particularly for contract manufacturers and outsourced processes, maintain robust oversight mechanisms with documented controls, regular audits, and clear delineation of responsibilities.

4. Maintain Electronic Systems Appropriately: While electronic document management improves efficiency, ensure that systems handling critical quality data maintain appropriate controls, including audit trails where required by risk assessment.

5. Foster a Quality Culture: Top management must visibly champion quality throughout the organization. This cultural commitment should be evident in how the organization approaches self-inspection, CAPA, and continuous improvement.

6. Prepare for Data-Driven Scrutiny: Modern FDA inspections increasingly rely on data analytics to identify potential issues before arrival. Ensure your data integrity practices are robust and that you can quickly provide electronic access to required information.

Conclusion

The success of our zero-observation inspection resulted from comprehensive preparation, strong management commitment, effective internal quality systems, and appropriate treatment of the inspection as a professional collaboration rather than an adversarial encounter. As the medical device regulatory landscape evolves with the implementation of QMSR and increased emphasis on international harmonization, these principles become even more critical.

I look forward to sharing additional FDA inspection response strategies and best practices in future seminars. The key message is clear: inspection readiness is not a periodic activity but an ongoing organizational capability that supports both regulatory compliance and genuine product quality that serves patients worldwide.

Note: This article reflects regulatory requirements and best practices current as of January 2026, during the transition period to the Quality Management System Regulation (QMSR). Organizations should consult current FDA guidance documents and regulations for the most up-to-date requirements.