FDA Keeps Issuing FSVP Warning Letters. Manufacturers Often Don't Know They're the Importer.

FDA inspected Life Plus Style Gourmet LLC in Plainview, New York, in 2022. Then again in 2023. The March 5, 2026 warning letter came after the third inspection in four years. The company imports specialty foods like tea, pasta, sauces, and snacks. None of them had a Foreign Supplier Verification Program on file, except for products from a single supplier.

Life Plus is not a one-off. FDA cited four importers in June 2025, another in November 2025, and multiple more in February 2026 ahead of the Life Plus letter. Enforcement is sustained, and Life Plus shows what happens when an inspector keeps coming back.

If you import any ingredient from a foreign supplier, even if customs paperwork says someone else is the "importer of record," you might be the company FDA expects to have a working FSVP. And if you don't, you're on the same path.

What FSVP Actually Requires

FSVP is a Food Safety Modernization Act rule, codified at 21 CFR Part 1 Subpart L under Section 805 of the FD&C Act. Every recent warning letter in this enforcement run cites the same section: 21 CFR 1.502(a).

In plain English, the rule requires US importers of food to do four things:

1. Analyze hazards in the food being imported

2. Evaluate and approve foreign suppliers based on those hazards

3. Conduct verification activities to confirm the supplier is controlling the hazards

4. Maintain records that prove you did all of the above

The verification activities can be audits, sampling and testing, record review, or something else risk-based. The key word is "verify." Trusting your supplier's own paperwork and shaking on it does not count.

USDA-regulated meat, poultry, and egg products are exempt at the time of import. Dietary supplement importers get modified requirements focused on CGMP compliance. Very small importers get modified requirements too. Everything else needs a full FSVP file.

The Importer Question Most Facilities Get Wrong

Here's the confusion that keeps showing up in FDA inspections. The FSVP importer is not the same thing as the Customs importer of record.

FDA defines the FSVP importer as the US owner or consignee of the food at the time of entry. Whoever owns the product or has agreed in writing to purchase it. That is almost always the manufacturer or buyer, not the customs broker, not the freight forwarder, and not the supplier's US sales arm unless the contracts say so.

If you buy imported cocoa powder for your bakery, you're probably the FSVP importer for that cocoa.

If you import spices from India to blend into your seasonings, you're probably the FSVP importer for those spices.

If your foreign supplier has a US sales entity and that entity is the importer on paper, verify in writing. The purchase agreement matters. Without it, FDA will look at who actually owns the food at entry, and the answer is usually you.

There's one escape hatch worth knowing. Manufacturers subject to the Preventive Controls rule who implement PC for the hazards in the imported food, or who comply with the PC supply-chain program, are deemed in compliance with most FSVP requirements for those foods. That's a real exemption, but only if your PC supply-chain program actually covers the imported ingredients in question. Double-check that yours does.

What Import Alert 99-41 Does to Your Business

FDA has a specific enforcement tool for FSVP failures that doesn't get nearly enough attention. Import Alert 99-41, published in August 2019, is called Detention Without Physical Examination for non-compliant FSVP importers.

Here's what it actually means. When FDA places your company on the Red List of this alert, every future shipment you bring into the United States is detained at the port. No physical exam. No chance to show it's safe. It just sits until you prove you're back in compliance.

Most FDA import alerts target foreign suppliers. This one targets you, the US importer. It's a different beast. The only way off is to petition the FDA Compliance Officer who placed you on it, with documentation showing the FSVP violations have been fixed.

The petition doesn't have a published timeline. Practitioners report it can take months. During that time, your imports are not moving. Your production line goes without those ingredients, or you scramble to source domestically at a markup. A fine is a check. This is a shutdown.

The 24-hour stress test a supplier-driven recall puts on your operation has a cousin here. Except instead of 24 hours of frantic tracing, you're looking at weeks or months of ingredient shortages while you rebuild a program the inspector already told you was missing.

The Three Gaps That Keep Getting Cited

Looking across the recent FSVP warning letters (Life Plus in March 2026, Ocho Rios Atlanta in October 2025, the four named companies cited in June 2025), the same patterns keep appearing.

No FSVP at all. The plainest violation, and the one that keeps showing up. The company imports food, has no hazard analysis, no supplier approval records, no verification activities. In the Life Plus case, the company had an FSVP for only one supplier out of its full import list.

FSVP that isn't being followed. A hazard analysis was done once, three years ago, and never updated. Supplier approvals are on file but no one conducts verification activities on the schedule the program says they should. Records exist but they stop at 2023.

Response without documentation. FDA's warning letter to Ocho Rios Atlanta noted the company responded to the agency's observations, but the response did not include any supporting FSVP records. Saying you've fixed the problem is not the same as showing proof. FDA treats an undocumented response as non-responsive, and the clock keeps running.

What to Check This Week

If you import any food ingredient, walk through this sequence:

1. Identify who the FSVP importer is for every imported ingredient. Not the customs IOR. The FSVP importer under the rule. If the contract is ambiguous, assume it's you until a written agreement says otherwise.

2. Match each imported ingredient to either an FSVP file or a PC supply-chain program entry. If neither exists for a given ingredient, you have a gap.

3. Check the date on every hazard analysis and supplier approval. If it's more than two years old and the supplier, product, or process has changed, it's probably stale.

4. Verify that verification activities actually happened on the schedule your program requires. A scheduled annual audit that hasn't happened since 2024 is the same as no program.

5. Keep records that show you did the work. If an FDA inspector can't read your audit report, your audit report doesn't exist.

The FSVP warning letter clusters in 2025 and 2026 are not evidence FDA decided to change its approach this quarter. They're evidence that a rule that's been around since 2017 gets consistent enforcement, with a real operational consequence attached. The companies that get caught are the ones who assumed FSVP was a paperwork exercise.

If your supplier qualification program runs on email threads and PDFs scattered across a shared drive, the next FSVP inspection is going to find what Life Plus found out the hard way. See what a supplier program designed to survive an FDA inspection looks like.