Why I Left the FDA After 17 Years

My personal testimony

For most of my career, I worked the other side of the table from the people reading this.

I spent 17 years at FDA. Thirteen of them as a Consumer Safety Officer walking the floors of food, beverage, and supplement importers around the Los Angeles District, and the last few as a Compliance Officer at a GS-13 level inside the Office of Import Operations, Division of West Coast Imports. That division covers the LA/Long Beach port complex, which is the busiest entry point for FDA-regulated goods in the Western Hemisphere. I wrote Warning Letters. I built Import Alert cases. I reviewed the 483 responses that came back from companies trying to keep their products on the shelf, and I was the one deciding whether those responses were good enough. So when I tell you I know what the agency is looking for, I mean I was the person looking.

People keep asking me why I left a stable federal job, and the honest answer has a few parts. I had a fantastic career at FDA, surrounded by mostly honest, hard-working people, and I learned a ton. But the agency is changing. Enforcement is shifting toward imports, FSVP, and the supply chain in ways that catch a lot of importers off guard. Import detentions have increased steadily over the past 10 years. PREDICT & ELSA keeps getting smarter about which entries to flag and firms to inspect. Meanwhile the companies on the receiving end of all this are often small importers who have never been through it before, and they're trying to read a Warning Letter at midnight wondering if their business is over.

I watched that happen a lot. And I started to notice something that bothered me.

The companies that struggled weren't usually the bad actors. They were the ones who didn't know the rules of the game. They'd respond to a 483 by promising to "do better" instead of building a corrective action plan that actually held up. They'd fight a detention with the wrong documentation. They'd treat FSVP like paperwork instead of a program, then act surprised when an investigator pulled it apart. None of it was malicious. It was a knowledge gap. And the people who could close that gap, the ones who actually knew how FDA thinks, mostly stayed inside the agency or charged enterprise rates that a small importer can't touch.

That's the gap I want to fill. I started SIG Consulting because the experience I built at FDA is more useful to you than it is sitting in a government office. I know how an investigator evaluates firms, because I trained investigators to do it. I know what a defensible Warning Letter response reads like, because I rejected the weak ones. I know how Import Alert petitions get evaluated, because I evaluated them. That's not theory I picked up in a seminar. It's 15,000-plus inspectional hours and a few hundred enforcement decisions.

One thing I want to be clear about, because it matters to me and it should matter to you: I will not touch any matter I personally worked on at FDA. That's an ethics line I don't cross. What I can do is everything on the advisory side. cGMP gap assessments. FSVP program design. Mock inspections. Import detention releases. Help getting your response right before it goes to the agency, not after it gets rejected.

I'm going to use this space to share what I actually saw on the inside. Not generic compliance advice you can find anywhere, but the stuff that changes how a real inspection or a real detention plays out. Some of it will be tactical. Some of it will be me thinking out loud about where enforcement is headed.

If you import FDA-regulated products and the agency has your attention right now, I'd rather you hear from me before the Warning Letter than after.

Dan Simonsen, Principal, SIG Consulting — sigconsultinggroup.com