Imagine you’re a student trying to pass a challenging class, one where the entire grade rests on the big test at the end of the semester. Fortunately, the professor handed out a syllabus that outlines exactly what will be on that final exam. Better still, you can also find a posted list of common mistakes previous test-takers made.

Given those resources, what are the chances you would still fail? Unlikely—unless you never bothered to study the material. In that case, you’d be like me trying to explain quantum mechanics after one five-minute YouTube video. (Spoiler: It didn’t go well.)

This is the reality of FDA inspections for companies in the life sciences. The federal agency effectively publishes its “syllabus” through regulations and guidance documents, while also releasing lists of common pitfalls companies face each year—documented as Form 483 observations. In spite of those resources, many companies still find themselves scrambling when inspectors knock on the door.

 …