Having awareness of a risk does not necessarily guarantee that it will be averted. Going along with the analogy Dr. Simon mentioned, if getting the form is similar to getting a speeding ticket, drivers are aware that speeding will result in them getting a ticket or worse from a police officer if they get caught. Being aware of the risk does not guarantee that it’s not going to happen. Admittedly, the analogy falls apart here for the reasons the repercussion happened, but I think that gets the point across. From working in the industry, I know that in fact medical device manufacturers do all they can in order to make sure they abide by all the rules and regulations that the FDA and other regulating bodies impose. A common practice is often having internal audits and reviews in addition to high quality standards. During these, auditors/reviewers will look for things that the FDA might look for in compliance/non-compliance. The good thing about doing this is that should something slip through the cracks, it’s caught by the company who can correct it with much less consequences than if the FDA caught it. Still, human error can often persist to the point that errors and non-conformances slip past all these checks and standards and results in getting Form 483 or any other repercussions that the FDA might issue.