That's why, when you are about to step into the FDA's purview, you hire people who have experience running a quality system which adheres to FDA guidelines or,

That's why, when you are about to step into the FDA's purview, you hire people who have experience running a quality system which adheres to FDA guidelines or, at a minimum, a consultant with similar experience. Ignorance is not a defense, and in practice, it doesn't really matter; they can shut you down, you can't do shit about it.