The FDA is a regulatory institution and therefore can do some serious damage to your company/employees if the audit uncovers irregularities that weren’t accounted for. I don’t have any examples personally, but the story the person above me sounds exactly like something that could potentially happen during an fda audit. Everything must be logged and everything must be traceable because the FDA will find out and does have the right to prevent you from commercializing your product and could potentially put your company in the red. Making medical devices costs millions of dollars through all the steps from initial design all the way through commercialization. Anything could happen if you fail an audit, like the individual above me described.