Blog

I hear this all the time: “I’m going to do my own FSVP program. I already signed up for the FSVP course. Once I finish it, I’ll be an expert and won’t need any help. I just want to ‘pick your brain real quick.’”Here’s the truth: that’s not how it works.An FSVP course by itself does not qualify you to carry out the activities required by FDA regulations. Under FDA FSMA, the Foreign Supplier Verification Program must be developed and overseen by someone with proper training and qualifications—specifically a Preventive Controls Qualified Individual (PCQI). That means yet another course, another level of training, and a much deeper understanding of food safety law and practice.What happens to most DIY importers is predictable:<ul><li>They take the FSVP course.</li><li>They think they’re set.</li><li>A regulator shows up, asks for documentation, and they freeze or say something silly.</li><li>Tempers flare, panic sets in, and now they’re in hot water with FDA. </li></ul>By the time we get involved, it’s usually after a warning letter, a bad inspection, a 483 citation, or pressure from their customers who are threatening to cut ties because they didn’t invest the necessary resources to comply with the law.This isn’t scare-mongering, it’s reality. FSVP compliance is not a “check-the-box” exercise. It’s a detailed, ongoing program that gets scrutinized by regulators, and it will make or break your business relationships.If you’re serious about importing food, you need to:<ol><li>Enroll in the right courses, not just FSVP but PCQI training.</li><li>Complete the required activities (supplier evaluations, hazard analyses, verification, recordkeeping).</li><li>Put in the time and effort to build a legitimate program.</li></ol>Once you see how much goes into it, you’ll probably realize what most serious companies do: you need a professional. A seasoned consultant will not only keep you compliant but will save you from costly mistakes that can tank your business.Bottom line: Don’t skimp out. FSVP is not something you DIY over a weekend. Do it right from the start, or pay much more dearly later when regulators and customers come down on you.&nbsp; Ready to Do It Right? At FSVP Advisors, we specialize in helping importers avoid the mistakes that sink businesses. We don’t sell courses, swindle companies into subcriptions, nor push unnecessary and expensive software. We build programs that stand up to FDA scrutiny and keep your customers confident in your compliance.Contact us today to schedule a consultation and get your FSVP program on the right track from the start.- Homero Ruiz, REHS/RS, PCQI

Why Just Taking the FSVP Training Alone Will Not Get You Compliant

The FDA’s Foreign Supplier Verification Program (FSVP) can be a complicated challenge for many importers. What many don’t realize is that the biggest reason companies fail isn’t always because the rules are too complex — it’s because they put the wrong person in charge.Far too often, I see the responsibility for FSVP gets handed off to someone unqualified: a sales manager, an office assistant, or even a relative who happens to be around. Maybe it’s a cousin, an uncle, or someone who means well but has no background in regulatory compliance.The problem is this is not a role you can “figure out as you go”. It requires years of experience in a food safety &amp; quality technical role and a strong science background. The FDA doesn’t give out brownie points for effort — they want you to comply with the law. If your food safety guy/gal lead can’t produce what they’re asking for, your business is the one that pays the price.Why FSVP Is Different Contrary to popular belief, FSVP is not “just paperwork.” It requires:<ul><li>Conducting hazard analyses for every product you import</li><li>Verifying that each foreign supplier meets U.S. food safety standards</li><li>Keeping detailed records</li><li>Taking corrective action when suppliers don’t meet your program requirements If the person you selected to develop or manage the FSVP program doesn’t understand food safety, risk assessment, and regulatory compliance, the entire program falls apart — and FDA will see right through it.</li></ul>The Risks of Putting the Wrong Person in Charge When importers assign the wrong person to comply with FSVP, the result is predictable:<ul><li>Warning Letters: FDA publicly posts your company name and violations online. Detained Shipments: Your products can be held at the border, costing you precious time and money.</li><li>Damaged Reputation: Customers and business partners see you as high-risk, and may stop working with you. Trust me they will drop you once they see a warning letter associated with your business.</li><li>Bigger Trouble Later: Repeat failures can escalate into more serious enforcement actions and even bar your business or even yourself as an individual from importing into the U.S.</li></ul>And all of this often starts because someone thought, “My cousin/homeboy/secretary can handle it.”Why Importers Make This Mistake<ul><li>Trying to save money: Owners assume anyone can fill out the forms.</li><li>Internal politics: Loyalty or family ties take priority over qualifications.</li><li>Underestimating the FDA: Many believe inspections won’t happen or that FDA won’t look too closely.</li></ul>But the FDA is watching. And when they inspect, they will expect your guy/gal to provide hazard analyses, supplier verification documentation, and records — not excuses.The Better Way Forward If you’re struggling to understand where to start with FSVP, here’s the truth:<ul><li>You need someone highly trained in compliance and food safety — not just someone with free time and a "can-do" attitude.</li><li>If you don’t have that person on staff, the safest option is hiring a consultant with extensive experience in this field.</li><li>Learning from past FDA warning letters can help you avoid from making the same mistakes as others. See link below for warning letters straight from the source:&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters" data-mce-href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters">https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters</a></li></ul>Final Word Your business is too important to gamble on. Don’t hand a key part of compliance like FSVP to your sales team, your admin assistant, or a family member who “will figure it out.” That’s not fair to them — and it puts your entire business at risk.If you want to avoid warning letters, detentions, and public enforcement records, the solution is simple: put the right person in charge.Contact us for a confidential FSVP compliance review before the FDA comes to visit.

The #1 Reason Importers Fail with FSVP? Putting the Wrong Person in Charge

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.&nbsp;

FSVP Compliance Blog

Why Just Taking the FSVP Training Alone Will Not Get You ...

The #1 Reason Importers Fail with FSVP? Putting the Wrong...

What do do when you get a FSVP Warning Letter