Most companies spend months preparing their documents for an FDA inspection. The reality is that the Investigator has already formed an opinion about your facility before your document coordinator brings out the first record.
I spent 14 years as an FDA Investigator and issued more Form 483s than I care to count. For the 13 years afterward, I was directly responsible for FDA 483s received at multiple companies. Here is something the industry does not talk about enough: the inspection does not start when the Investigator sits down and asks for your batch records. It starts the moment we pull into your parking lot. Sometimes earlier – the night before, reviewing your establishment inspection history, your prior 483 observations, and every Warning Letter your site or your parent company has ever received.
By the time you hand us a document, we already have a working theory about your facility. What happens for the rest of the inspection, in many respects, is testing that theory.
What Investigators Are Actually Watching
There are seven specific things every experienced Investigator notices before a single document changes hands – moments during the walkthrough, the opening meeting, and even the parking lot approach that set the tone for everything that follows. None of them show up in your document control system. None of them are improved by spending the week before an inspection pulling records and checking completeness.
What they reflect is the actual operating condition of your quality culture – the day-to-day reality of how your facility is managed when FDA is not watching. That is the point. Investigators are not trying to catch you in a bad moment. They are trying to determine whether the good moments are the norm or the performance.
Why This Matters More Than Most QA Teams Realize
The facilities that do well in FDA inspections are not the ones that prepare hardest in the two weeks before an Investigator arrives. They are the ones where the parking lot is maintained because someone cares about maintenance, where the floor staff compose themselves during a walkthrough because training happened last month and not last year, and where the quality director can speak fluently about an open CAPA because the real state of the quality system is something they are willing to stand behind.
That kind of facility takes years to build. It cannot be staged. And it is exactly what an Investigator is evaluating before they ever ask for a record.
The complete list of seven observations – including the specific behavioral and physical signals Investigators are trained to notice, and the corrective actions that change what an Investigator concludes before the formal inspection even begins – is available to paid subscribers of The Investigator’s Lens.
Link: https://devaughnedwards.substack.com/p/221?r=7sflcx
Questions about your facility’s inspection readiness: devaughn@fdaid.org | fdaid.org
ยฉFDAID LLC 2026
FD-AID | FDA Inspection Readiness | Former FDA Investigator 