What happens after a U.S. Food and Drug Administration (FDA) inspection can affect regulatory risk, business continuity, and compliance in clinical trial settings. This session will explain the FDA’s post-inspection process and outcomes, including FDA Form 483 (Inspectional Observations), Establishment Inspection Reports, Untitled Letters, Notice of Initiation of Disqualification Proceedings and Opportunity to Explain letters, and determinations of No Action Indicated, Voluntary Action Indicated, and Official Action Indicated.

Attendees will learn how the Agency evaluates findings, reviews responses, and decides next steps, and will gain a practical understanding of the key documents issued at the end of an inspection and FDA decisions that can lead to Warning Letters or enforcement. With a focus on root cause analysis and Corrective and Preventive Action Plans, this session will explain what each outcome means from regulatory and operational perspectives, helping attendees anticipate risk, prioritize responses, and communicate effectively across teams. Attendees will leave with practical strategies and greater confidence in managing observations, reducing escalation risk, and improving inspection readiness.

CEU: 1.0 ACRP

Speaker:

• Janet Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer, Holwell Clinical Research Consulting