Basically what the FDA looks for when they do an audit is to ensure all the documentation is proper and all the protocols are being followed properly. The FDA will try to find anything to mark down. They are not doing to harm the company but only to improve it. The FDA wants to make sure there are no hazards and no shortcuts are being taken to get the product on the line. This is one of the main reasons FDA takes a while to approve products and also why many products are being recalled. They’re main goal is to ensure the safety of the users so that is why the FDA looks for the design control system to be in tact and proper.