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Preparing for Success – How to have a positive FDA Inspection

Success does not come about by coincidence. Success is an outcome of preparation. When it comes to successful U.S. Food and Drug Administration (FDA) inspection outcomes, preparation is at the foundation. Finding out that the Site is not in a position to meet the Agency’s requirements during the process of the Inspection is not a desirable position for any site. Unsuccessful FDA inspections can impose a long time impact on a company’s strategic plan.

Those of us who had experience with FDA inspections are well aware that they can be challenging. However, the chances of having the inspection process run as smoothly as possible can be greatly improved by implementing the proper preparational tools. In the following article, we will discuss a few simple but useful tools and offer guidance that you, and your team, can use to help you set up for success in your next FDA inspection.

Ship Shape

First impressions are everything. You have worked hard as a team to get your site to where it is, now take pride and show it off at its best. It is important that the areas the Inspectors are going to see are clean, tidy and in a state of control. This does not just include the inspection areas, all areas that the Inspectors are going to see the need to be treated in the same manner. If your areas are well presented, clean, tidy, and organised this will build the Inspector’s confidence in the Site. Sites that are visually well-maintained and well-presented speak to the Site attitude as a whole. Consider the implementation of a 5S program in your area. 5S helps to establish an orderly work environment in addition to improving efficiency. Some helpful tips on how to implement a 5S program can be found here.