FDA inspections are a critical part of regulatory oversight for medical device manufacturers and play a key role in ensuring compliance with U.S. Food and Drug Administration (FDA) requirements. Proper preparation can significantly influence inspection outcomes, reduce compliance risks, and support continued market access. This presentation, “5 Tips for Getting Ready for an FDA Inspection,” provides a practical and structured overview of inspection readiness for medical device companies. It is designed to help quality, regulatory, and operations teams understand what to expect before, during, and after an FDA inspection, with a focus on compliance with 21 CFR Part 820 (Quality System Regulation). The slides explain the purpose of FDA inspections, why inspection readiness matters, and how poor preparation can impact approvals, business continuity, and organizational reputation. The presentation outlines key best practices such as pre-inspection planning, inspection team readiness, document control, facility preparedness, and effective communication with FDA investigators. Special attention is given to managing inspector arrival, handling document requests, conducting facility tours, and maintaining clear and professional communication throughout the inspection process. The presentation also covers exit meetings, FDA Form 483 observations, and the importance of timely and effective post-inspection follow-up actions, including corrective and preventive actions (CAPA). This educational resource is intended for medical device manufacturers, regulatory affairs professionals, quality assurance teams, startup founders, and compliance leaders who are responsible for maintaining FDA compliance and inspection readiness. The content is presented in clear, easy-to-understand language and avoids promotional or sales-oriented messaging. The presentation serves as a general awareness and preparedness guide for FDA inspections and supports organizations in building a proactive compliance culture aligned with FDA expectations. For additional reference, visit: https://operonstrategist.com/fda-inspection/?utm_source=google&utm_medium=off-page&utm_campaign=offpage8