In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. In this exercise, I do not try to prove causation. I am simply exploring correlation. But with that caveat in mind, I think it’s still informative to see what types of inspectional citations, in a high percentage of cases, will precede a warning letter. And, as I’ve said before, joining two different data sets – in this case inspectional data with warning letter data – might just reveal new insights.
Continue Reading Unpacking Averages: Device Inspection Citations That Frequently Precede Warning Letters