A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to prepare for each stage?

Here are answers to a number of frequently asked questions about FDA inspections and compliance actions. These answers are designed to be generally applicable, rather than addressing a specific type of product. In future client guides, we will discuss some specific items for food, drugs and medical devices, and some likely changes that FDA will make pursuant to new laws, such as the FDA Reauthorization Act of 2017 and the FDA Food Safety Modernization Act (FSMA).