Well if they were planning on going to market without being able to pass an audit then they deserve every bit of it. I've worked in am FDA regulated field for a

Well if they were planning on going to market without being able to pass an audit then they deserve every bit of it. I've worked in am FDA regulated field for a little over a decade and getting in touch with regulatory bodies up front is par for the course. Sounds to me like they don't know what they're doing and are in over their heads.