FDA audit could be nerve-racking for medical device manufacturers if they are not well prepared. Over the last few years, medical device firms have encountered a significantly heightened number of inspections that resulted in increase in the number of citations. Although difficult, FDA audit is an important aspect of medical device industry. However, especially for startups, the first audit could be quite difficult to handle as the checklist of FDA could scare away the potential investors or customers, hindering the organization’s goal and efforts. Moreover, FDA sometimes announces their audit beforehand but the regulators may also turn up any time for inspection, without any notice. This implies, being a medical device manufacturer, you always need to be prepared for going through an FDA audit.