Ahoy, mateys! Batten down the hatches and hold onto your manifests, because the FDA’s on the prowl, issuing Warning Letters like they’re going out of style! If you’re in the business of importing FDA-regulated products, particularly food, you’re probably well aware of the Foreign Supplier Verification Program (FSVP). And if you’re not—well, now’s the time to listen up. The FDA has been on a bit of a tear lately, cranking up the frequency and scrutiny of FSVP inspections, and companies need to be ready or risk walking the plank.
The Current State of the FDA’s FSVP Inspections
For those who might be new to the FSVP party, here’s a quick rundown: the FDA’s FSVP rule requires importers to verify that foreign suppliers are meeting U.S. safety standards. The ultimate goal? Ensuring that imported foods are as safe as domestically produced foods. The FDA rolled out this program under the Food Safety Modernization Act (FSMA), making it a cornerstone of their efforts to prevent foodborne illness.
Recently, the FDA has been issuing a flurry of Warning Letters to companies that failed to comply with FSVP regulations. Think of these Warning Letters as strongly worded notes with a hint of legal threat. The FDA has indicated that they’re not messing around, and inspections are coming in hot and fast. In fiscal year 2023 alone, the FDA conducted thousands of FSVP inspections, and they’ve continued to ramp up their efforts in 2024. And while this could be the FDA’s way of getting their steps in for the year, there’s clearly a method to their madness.
The recent flurry of FSVP Warning Letters include Warning Letters issued to JC Finest Produce and Green Day Produce, Inc., posted October 8. FDA found that JC Finest Product did not develop, maintain and follow an FSVP as required by Section 805 of the Federal Food, Drug and Cosmetic Act (FDCA). Separately, the FDA found that Green Day Produce did not evaluate its foreign suppliers including the supplier’s compliance with applicable FDA food safety regulations. Additionally, the FDA found that the company’s supplier verification activities did not provide adequate assurance that the hazards requiring a control in the foods imported have been significantly minimized or prevented. FDA also published Warning Letters issued to Troya Del Campo, JJH Trading, Pacific Exchange Distributors, and Warbucks Seafood, all over the span of 1-2 months.
Inspection Frequency and Priorities: The FDA’s Game Plan
The FDA isn’t just going for a stroll—they’re strategic. Their inspection frequency is based on a variety of risk factors, such as:
- The Type of Food: Foods prone to contamination (like raw seafood, sprouts, and fresh produce) tend to be inspected more frequently.
- Supplier History: If a supplier has a history of compliance issues, they can expect more regular check-ins from the FDA.
- Country of Origin: Yes, geography plays a role. Countries with known food safety issues are more likely to attract the FDA’s attention.
- Importer Compliance History: If a company has a track record of infractions, they’re definitely on the FDA’s radar.
In a nutshell, the FDA is using data to prioritize which companies and products to inspect. And with the emphasis on foreign suppliers, importers are squarely in the crosshairs. This means a sudden knock on the door from the FDA inspector is more a matter of “when” than “if” these days.
What Does an FSVP Inspection Look Like?
The FDA is pretty thorough when they come knocking. An inspector will want to review your FSVP records, which need to demonstrate that you’ve done your due diligence to verify that your foreign supplier’s food is safe. The FDA’s goal is to confirm that importers:
- Have a documented FSVP plan.
- Are actively verifying that their foreign suppliers are in compliance with U.S. safety standards.
- Are conducting hazard analysis and supplier verification activities (think sampling, testing, and auditing).
- Have implemented corrective actions if needed.
Failure to meet any of these requirements can result in a Warning Letter, and that’s just for starters. If the FDA deems your non-compliance to be egregious, they might escalate to placement on Import Alert (adding lots of extra hoops to get product in), product seizures, injunctions, or even criminal charges. No one wants to go to jail for an improperly vetted box of avocados, right?
How to Stay Off the FDA’s Wicked List: Tips for FSVP Compliance
So, how can you avoid a strongly worded letter from the FDA? Here are key tips:
- Keep Those Records Tight: FSVP is all about documentation. Keep detailed records of everything, from your hazard analyses to your supplier audits. And don’t just stuff them in a drawer somewhere; make sure they’re easily accessible for an inspector.
- Vet Your Suppliers: Conduct thorough due diligence, which can include reviewing supplier audits, testing samples, and confirming that their safety practices meet FDA standards.
- Stay Updated on FDA Guidance: The FDA occasionally updates its guidance on FSVP requirements, so make sure you’re aware of any changes. Ignorance of the law is no defense, and the FDA isn’t interested in excuses.
- Train Your Team: FSVP compliance is a team effort, so make sure everyone involved in your import operations knows the rules. This means offering training on FDA regulations and how to maintain compliance. Remember, you’re only as strong as your weakest link!
- Work with FDA counsel: If FSVP requirements sound more like alphabet soup to you, consider bringing in outside FDA counsel who can help ensure that your FSVP plan is bulletproof and that you’re fully prepared for an inspection.
A Final Word: Beware the Burst of Warning Letters!
The FDA’s ramped-up inspections and subsequent issuance of Warning Letters are a not-so-gentle reminder that they’re watching, and they expect importers to be on top of their FSVP game. If you’re an importer, now’s the time to batten down the hatches and make sure your FSVP plan is shipshape. Remember, compliance isn’t just about avoiding a slap on the wrist—it’s about protecting consumers and building trust in your products.
So, grab your FSVP binder, rally your team, and make sure you’re ready for that FDA knock on the door. The high seas of FSVP compliance may be daunting, but with some preparation and vigilance, you’ll stay afloat and avoid those dreaded Warning Letters. Sail on, intrepid importer, and may the FDA winds be ever in your favor!
For more information on U.S. FDA FSVP requirements, assisting with FSVP plans, preparing for an FDA FSVP Inspection, or responding to a 483 or Warning Letter, or for other FDA compliance and enforcement questions, please email info@garg-law.com.
