Irritating topic and Damocles sword "FDA Audit"! Who doesn't know that? At least if you manufacture products in a regulated environment and sell them in the USA that fall under the jurisdiction of the FDA (Food and Drug Administration), you will be confronted with this topic. There is a permanent latent danger that an audit of this authority is pending. What you do during the audit and what you better not do is described in this blog entry in a very practical way.