What do do when you get a FSVP Warning Letter

Let’s be clear: if you are reading this, you’re already in deep trouble. An FDA Warning Letter is not a “friendly reminder.” It’s a formal notice that your business has been determined to be in serious violation of FDA food regulations — and the clock is ticking. You have 15 days to take action and are now on the FDA’s radar. The worst part is the agency doesn’t just forget about you. They will be back to check on your progress.

Here’s what you have to do:

1. Don’t ignore it.
Shoving it in a drawer, or acting like you didn't understand it, won’t make it disappear. Inaction is the fastest route to an injunction, import refusal, or worse.

2. Read it. All of it.
Understand exactly what the is being requested of you in the letter. Every point matters — and every point needs to be addressed.

3. Don’t fire off a knee-jerk response.
The worst thing you can do is send something like “Got it” or “We’ll take care of it.” That is not the response an FDA officer is looking for. In fact, that’s a red flag to signal that you are completely clueless. They will not be amused.

4. Build a real, achievable corrective plan.
Your response should show that you understand the violations, have a concrete plan to fix them, and have evidence to prove it. The FDA does not take well to empty promises. If you don’t know how to do this — call me. I can help you.

5. Document everything.
Keep a full record of all official FDA correspondence, emails, notes, as well as evidence of corrective actions. If the FDA comes back, you want to have proof you are making a reasonable effort to comply.

6. Follow through — for real.
If you don’t, the next step is likely a “Detention Without Physical Examination” (DWPE), or an indjunction. In plain English: this means your products will either be detained and/or won’t make it past the border upon arrival into the US.

Bottom line:

An FDA Warning Letter is a flashing red light. Treat it seriously, act strategically, and get expert help if you’re in over your head. Otherwise, you risk losing the ability to import, and possibly your business.