If you manufacture, process, package or hold drug products you will be inspected by the FDA. The FDA has defined criteria based on which they would decide on the timing and frequency of investigating a drug establishment. It is incumbent on you to always be in compliance and prepared for such inspections. In this presentation we will review the overall criteria the FDA uses to decide on the location, timing and frequency of an inspection. We will also review the systems that will be inspected and look at many recent FDA 483 observations to identify what happens during the inspection. Finally we will review some of the actions that you may take to prepare for these inspections.

The presentation will begin by reviewing the criteria the FDA uses to define their inspection target, the frequency of inspection and the timing. We will then briefly review the various types of GMP inspections. The presentation will then focus on the "System Based Inspections" normally conducted by the FDA. In order to understand the system based inspections, we will first define what the FDA will look for in each system, and then review many of the 483 observations that have been recently given to drug producers and relate them to the various systems. We will then review in broad terms how to insure that you are in compliance and ready for an FDA inspection at all times.