This document outlines steps to take when FDA inspectors arrive for an audit. It advises preparing key personnel and minimizing major activities if the visit is expected. If unannounced, call necessary people like management and QA and take the inspectors to a meeting room. Obtain their purpose and audit plan. Guide the inspectors but let them lead the process, and take notes on discussions. Provide information to areas being audited and discuss logistics like timing. Pull in resources and be courteous and professional throughout the inspection.