FDA Investigators do not spend the entire inspection with your Quality Director. At some point, they walk the floor. They talk to line operators, lab technicians, warehouse staff, and QC analysts – people who did not attend the opening meeting, who have not been rehearsed on how to handle an inspection, and who are going to answer questions the only way they know how. Honestly.
That is not a criticism of your employees. It is a description of exactly what FDA is counting on.
I spent 14 years as an FDA Investigator and issued more Form 483s than I care to count. For the 13 years afterward, including part of the team that navigated J&J out of consent decree, I was directly responsible for FDA 483s received. I know the six questions that reveal the gap between what your SOPs say and what your employees actually do faster than anything else. I asked them myself for 14 years.
The Questions Are Not Random
The questions Investigators ask floor staff are deliberate, specific, and designed to surface one thing: whether the quality system that exists in your documentation also exists in the heads and hands of the people executing it every day.
A quality system that lives only in documents is not a quality system. It is a library. And FDA does not inspect libraries. They inspect operations.
The tone when these questions are asked is almost always conversational. Calm. Friendly, even. That is intentional. A relaxed employee answers more freely than a nervous one. And a free answer – one that has not been carefully constructed by a quality manager – is exactly what the Investigator is looking for.
What the Wrong Answer Costs You
The wrong answer does not just create an awkward moment on the floor. It hands the Investigator a thread they will pull for the rest of the inspection. A single employee who cannot describe their escalation pathway, who is vague about data integrity controls, or who hesitates in a way that suggests they have been coached on what to say rather than trained on what to know – that employee has just told the Investigator where to look next.
The facilities that answer these questions well are not the ones that spent the week before the inspection coaching their floor staff on what to say. They are the ones where training is role-specific, current, and regularly reinforced. Where deviation reporting is encouraged rather than discouraged. Where the right behaviors happen on a random Wednesday because that is simply how things work here – not because an Investigator is watching.
That kind of operation does not get built in a week. But the gaps in your current operation can be identified and addressed before FDA identifies them for you. That is the difference between a 483 observation and a clean inspection.
The six questions Investigators ask floor staff – the exact language used, what a strong answer sounds like, what a weak answer signals, and the specific 483 observations each question is designed to surface – are detailed in the full article on The Investigator’s Lens.
Questions about your facility’s inspection readiness: devaughn@fdaid.org | fdaid.org
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FD-AID | FDA Inspection Readiness | Former FDA Investigator 