FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The scary part is having to explain the error of your ways to the FDA and above all, managing an administrative action, e.g., Warning Letter or Import Alert, or a legal action, e.g., civil money penalties, seizure, injunction or prosecution.
Who will Benefit:
When you interact with the FDA, you need to look at yourself through FDA’s eyes. You can understand the purpose of an inspection, what the investigator will do and what it means for you. Once you learn how to read the signals you are better equipped to mitigate regulatory damage and, best of all, take the drama and mystique out of an inspection.
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