What a 30-Year FDA Veteran Wants You to Know Before Your Next Inspection

When we asked food safety professionals attending our most recent FSMA Friday how they'd rate their facility's FDA inspection readiness, nearly half said "moderate." Not strong. Moderate.

That gap is exactly what Don Kautter spent the session closing.

Don served 30 years at the FDA as a Senior Advisor and Consumer Safety Officer at the Center for Food Safety and Applied Nutrition. He led enforcement decisions on warning letters, recalls, injunctions, and compliance directives — the kind of actions that end careers and close facilities. He's seen inspections go well. He's seen them spiral. He knows why the difference usually isn't what you think.

This FSMA Friday recording is worth an hour of your time. Here's what's in it.

Don's central point runs through the entire session: the facilities that come out of FDA inspections cleanly prepared before the knock on the door. Not the night before. Not when the investigator walked in.

That preparation has a specific shape. It starts with a trained inspection team — people who know their roles the moment someone shows up, not people figuring it out in real time. It includes mock inspections, ideally run unannounced so the conditions match what an actual FDA visit looks like. It means having a Dear Investigator letter ready to hand over at the start, one that sets your facility's expectations around photographs, document requests, escort policies, and how questions will be directed to line workers.

It also means having a scribe assigned who follows the investigator throughout the inspection, logging observations, noting what's being photographed, and tracking every concern raised so nothing surfaces as a surprise during closeout.

Don is clear that all of this should be practiced before it's needed. The facilities that struggle aren't the ones with the worst food safety programs — they're often the ones with decent programs and no rehearsal for how an inspection actually runs.

The IOM — the FDA's Investigations Operations Manual — is publicly available and details exactly how inspectors conduct their work. Don recommends it as required reading for any inspection team. Most facilities haven't looked at it.

Beyond documentation, inspectors evaluate five things Don returns to throughout the session: transparency, professionalism, preparedness, documentation accuracy, and food safety culture. That last one gets measured in conversation — the exchanges investigators have with line workers, supervisors, and management, and whether those conversations tell a consistent story about how the facility operates every day, not just when the FDA is present.

Which brings Don to the red flag statements he's heard across his career — phrases that make investigators dig harder. "We've never had that problem before." "Corporate handles that." "That's how we were trained years ago." "We only do that when the FDA is here." Each signals something the investigator will follow up on. Don explains exactly what that follow-up looks like and how to avoid putting your team in that position.

Don doesn't stay at the strategic level. He walks through the scenarios QA managers actually face: the investigator who starts pulling documents you haven't reviewed yourself, the 483 you weren't expecting, the disagreement that needs handling without escalating.

His guidance is precise. How to set up a dedicated inspection space before the investigator arrives. What to say when you don't know the answer to a question — and what not to do with that moment. When to escalate to legal, and how to do it without raising flags. Why you should take your own photographs when the investigator takes theirs, and why zooming out for context matters as much as the close-up shot. How to provide documents appropriately marked, logged, and reviewed before they leave your hands.

He's also direct about something most facilities don't fully act on: the inspection isn't over when the investigator leaves. Your written response, your corrective action tracking, and whether the agency finds the same issues it flagged last time  and whether you show up at the next inspection with repeat observations — that's the full picture the FDA evaluates. Facilities that respond well to a 483 can turn a difficult inspection into a credibility moment. The ones that don't compound the problem.

The closeout gets its own section in Don's presentation, and for good reason. This is where facilities either land well or leave loose ends that become the first agenda item at the next inspection.

Don's advice: listen carefully, take detailed notes, and make sure you fully understand each observation before the investigator leaves — not just what they saw, but why they consider it a food safety issue and how it connects to your process. If there are corrections you can make on the spot, make them and document them. If corrections will take time, commit to timelines and put them in writing.

The written response to the agency should go out within 15 days. It doesn't need to close every item (some corrections take weeks or months) but it needs to show that you understand what was found, you're taking it seriously, and you have a plan with dates attached.

Don recommends a formal internal debrief within 24 to 48 hours of the inspection closing. That's when the scribe's notes, the photographs, and the inspection team's observations are freshest, and when root cause analysis on significant findings should begin. Everything gets documented. Timelines get assigned. Someone is accountable for tracking each commitment to completion.

One of the strongest sections of the session addresses what most inspection prep content ignores: what happens between inspections matters as much as what happens during one.

Don outlines six foundations for long-term regulatory credibility: consistent compliance, responsiveness to identified issues, proactive environmental monitoring where applicable, ongoing training, a continuous improvement mindset, and maintaining dialogue with regulators when issues arise. That last point surprises some people. Don is direct that reaching out proactively, when there's something to report or resolve, builds more credibility with the agency than going silent and hoping the next inspection goes fine.

The live questions get into territory Don's presentation doesn't cover: how inspection priorities have shifted under the current administration, what to do when you don't receive a written 483, how to handle state inspectors operating under FDA contract, and where to find training resources for the FSMA agricultural water rule. His answers are direct and grounded.

Don spent 30 years on the other side of the table. This session is an hour of practical knowledge that usually only comes from hard experience or from knowing someone with his background. Watch it, share it with your inspection team, and use it to pressure-test your preparation before your next regulatory visit.