If you receive a Warning Letter from FDA, do you know what to do? There are ways to handle it and there are things not to do. If you do the wrong stuff, you are getting started off on the wrong foot with FDA and then they can really make your life miserable. The first thing to do is answer the letter within 10 days.
Did you know, because of FSMA, FDA can suspend a company’s registration even if they only have reasonable probability that the product in your plant may become contaminated? They don’t have to find specific examples anymore.