Navigating FDA Inspections: Practical Steps For Clinical Supply Leaders, Part 2
By Kimberly Chew, senior counsel, Husch Blackwell LLP
In today’s rapidly evolving regulatory environment, the approach to FDA inspections is undergoing significant transformation. The COVID-19 public health emergency accelerated the FDA’s adoption of remote regulatory assessments (RRAs) — virtual inspections that allow regulators to review facilities and records without setting foot on-site. With the FDA’s final guidance on RRAs published in June 2025,1 remote audits have become a permanent fixture alongside traditional in-person inspections. As a result, organizations must now be equally prepared for both formats.
In Part 1 of this series, we explored how to build a strong foundation of compliance and data integrity within clinical supply operations. In this article, we shift our focus to the practical steps clinical leaders can take to prepare for, manage, and respond to FDA inspections, whether conducted on-site or remotely.
From understanding the different types of regulatory inspections to developing proactive readiness strategies and responding effectively after an audit, the following best practices will help your organization maintain high standards of quality, accountability, and regulatory compliance at every stage of the inspection process.
Understand Regulatory Inspections: What To Expect
Understanding what to expect during a regulatory inspection is essential for clinical supply teams to prepare effectively and respond confidently. FDA inspections can target different aspects of the clinical supply chain, each with its own focus and triggers. For-cause inspections are initiated in response to specific complaints, adverse events, or identified supply chain failures.2 Pre-approval inspections are conducted to assess IP management and documentation before a product receives approval.3 Routine surveillance inspections are designed to evaluate ongoing compliance with GCP and other regulatory requirements.
During these inspections, FDA inspectors may closely review a range of critical supply chain activities and records.4 These include product labeling, packaging, and storage practices, as well as shipping and distribution records.5 Inspectors will also examine vendor oversight and qualification, documentation of deviations and the effectiveness of corrective or preventive actions, and the completeness of temperature excursion logs and the corresponding responses.6 By understanding the scope and focus of these inspections, organizations can better anticipate regulatory expectations and ensure robust preparedness across all areas of their clinical supply operations.
A significant recent trend in FDA inspections is the increased use of RRAs. As remote audits become more common, clinical supply teams must ensure that electronic systems are robust, records are readily accessible, and staff are prepared to communicate and collaborate effectively in a virtual environment. Being audit-ready now means being prepared for both traditional on-site inspections and remote assessments, further underscoring the importance of strong data management and digital infrastructure.
Be Inspection Ready: Proactive Steps For Supply Leaders
To achieve true inspection readiness, clinical supply leaders must adopt a proactive and systematic approach to compliance. Regular internal audits are essential for identifying and addressing gaps, inconsistencies, or protocol deviations within the supply chain before they escalate into regulatory issues. Clarifying roles and responsibilities is equally important; maintaining up-to-date delegation logs for all staff involved in supply chain activities ensures accountability and smooth coordination. Assigning clear roles for inspections, such as identifying who on the team will act as host, scribe, and document retriever, helps ensure that everyone knows their responsibilities if an inspection occurs. Periodic mock inspections provide valuable opportunities to test the team’s readiness, uncover potential weaknesses, and reinforce best practices.
Effective vendor management is another key component. Supply leaders should verify that all third-party vendors, including storage facilities, couriers, and packaging facilities, are qualified, compliant, and audit-ready. This includes routinely reviewing vendor contracts to confirm that regulatory requirements are clearly addressed.
Finally, a robust communication plan is vital; all staff, including reception, should be trained on how to respond if an inspector arrives, and there should be a clear protocol for who communicates with inspectors and how information is shared within the organization. By taking these proactive steps, supply leaders can foster a culture of preparedness and minimize the risk of regulatory surprises.
During The Inspection: Best Practices
During an FDA inspection, following best practices is essential to ensure a smooth and transparent process. Start by confirming the inspector’s official credentials and obtaining the Notice of Inspection (FDA Form 482) before any activities begin. Clarify the scope of the inspection by asking about the specific areas of focus, and make sure to document all questions, requests, and responses. Assign clear roles within your team: the primary host should manage all communication with the inspector, a scribe should carefully document every interaction, and a document retriever should be responsible for providing timely access to requested records.
Throughout the inspection, maintain real-time communication with your team to keep everyone updated on the progress and to address any issues as they arise. Respond to inspector questions with facts and supporting documentation, prioritizing transparency at all times. If you do not know the answer to a question, it is acceptable to defer and follow up with accurate information as soon as possible. Additionally, keep a detailed log of every document or record requested by inspectors, noting how and when each was provided. By adhering to these best practices, organizations can demonstrate their commitment to compliance and facilitate a constructive inspection experience.
After The Inspection: Responding And Improving
After the inspection concludes, it is crucial to conduct an internal debrief with your team to review the inspection findings and discuss immediate next steps. If the FDA issues a Form 483 (Inspectional Observations), respond promptly with a comprehensive written reply within 15 business days. Your response should address each observation in detail, outlining specific corrective actions and timelines for implementation.
Beyond simply addressing regulatory findings, use the inspection outcomes as an opportunity to drive meaningful process improvements and to provide targeted training to staff. It is also important to remember that Form 483s can be requested by the public, so your written responses should be professional, thorough, and demonstrate a genuine commitment to compliance. By taking these steps, organizations can not only resolve inspection findings but also strengthen their overall quality systems and readiness for future inspections.
Conclusion
In today’s regulatory landscape, inspection readiness is a continuous journey that demands diligence, collaboration, and a culture of compliance across all levels of clinical supply operations. By embedding compliance into daily routines, safeguarding data integrity, understanding inspection processes, and proactively preparing both staff and vendors, clinical supply leaders can protect their organizations from regulatory setbacks and support the successful delivery of investigational products. Each inspection — whether anticipated or unexpected — offers an opportunity to strengthen processes, reinforce accountability, and demonstrate a commitment to patient safety and product quality. Ultimately, a well-prepared organization not only meets regulatory expectations but also earns the trust of sponsors, investigators, and patients, paving the way for successful clinical trials and future innovation.
References
- U.S. Food & Drug Admin., Conducting Remote Regulatory Assessments—Questions and Answers (June 2023), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers
- 21 U.S.C. § 374(a); 21 CFR § 312.68
- 21 U.S.C. § 374(a); 21 CFR 314.125(b)(13)
- 21 U.S.C. § 374(a); 21 CFR § 312.68
- 21 U.S.C. § 374(a); 21 CFR § 211.122; 21 CFR § 211.142; 21 CFR § 211.150
- 21 CFR § 211.80(a); 21 CFR § 820.50; 21 CFR § 211.100; 21 CFR § 211.192; 21 CFR § 820.100; 21 CFR § 211.142; 21 CFR § 211.160(b)(4)
About The Author:
Kimberly Chew is senior counsel at Husch Blackwell LLP’s virtual office, The Link. With a robust background in biotech research, she guides clients through the complexities of clinical trials, FDA regulations, and academic research compliance. As cofounder and co-lead of the firm’s Psychedelic and Emerging Therapies practice group, Kimberly is passionate about advancing psychedelic therapeutics for mental health. Her practice also includes regulatory due diligence and intellectual property enforcement, with a particular focus on patent infringement and validity. She can be reached at kimberly.chew@huschblackwell.com.