The Regulatory Expert · Supplier Programs
got compliance?
You import ingredients. FDA wants proof you checked out the people you buy from. That's a supplier program, and you don't have one. No worries, I know a guy.
Send me your listIt's free.Who this is for.
Importers, brokers, distributors. Botanicals, spices, teas, extracts, powders. Supplement brands. Three SKUs or thirty. If you bring ingredients into the country and somebody else makes the finished product, this is you.
Who it's not for.
Meat, seafood, juice, fresh produce, anything in a can. Different rules, different guy.
No FSVP? You've got company.
It's the number one thing FDA writes importers up for. Not a bad program, no program. And your customers aren't waiting on FDA to ask you for one. Walmart won't take an FDA inspection as proof of anything. Neither will Amazon.
Import Alert 99-41 is what happens when it goes sideways: every shipment held at the border until you fix it. Let's not.
What you get.
The written program. An approved supplier list you can actually keep up with. A hazard assessment on every ingredient: metals, pathogens, adulteration, the works. A testing plan that says which tests, how often, and why. A filing system with version control, because FDA asks for these documents and records by email and gives you 24 hours.
You align to it. I got the rest.
Domestic suppliers too. Same program, different section of the rulebook.
What it costs.
Most small importers land between four and eight thousand to build it. Depends on how many suppliers and how many products you've got. Then a few hundred a month if you want me to stay on as your Qualified Individual, which the regulation allows, in so many words.
Got a unique situation? Send me the details and I'll send you the scope of work and cost.
Why TRE.
More than 25 years of compliance. PCQI, FSVP, and HACCP certified. I've sat across the table from FDA inspectors, and I've built these programs from nothing for companies that had nothing. I get passionate about this stuff. I'll still match your risk tolerance and your budget.
Not sure what you've got?
Send me your supplier and ingredient list. Spreadsheet, email, a photo of the whiteboard, it doesn't matter. I'll send back a read on where the gaps are and what it'd take to close them. Free. No call unless you want one.
Compliance? I know a guy.
Looking forward to meeting you.