FSVP Warning Letters Hit a Three-Year High: 15 in Four Months and the One Mistake Every Importer Made

The pattern in FDA's 2026 enforcement docket is hard to miss. Between January 1 and April 23, FDA published 15 warning letters citing violations of the Foreign Supplier Verification Program. That is 67% above the same window in 2024 and the same percentage above 2025. A 16th letter, to The Wilatta Group, posted on April 28. All of them name the same core failure.

Read the letters back-to-back and one sentence appears in nearly every one:

"You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import."

Not a defective FSVP. Not a thin one. No FSVP at all. More than a decade after the FSVP rule was finalized in November 2015, that is still the most common finding when an FSVP investigator walks in the door.

This post lays out who FSVP covers, what FDA is actually checking, the escalation path that ends in your goods being detained at the port, and the work an importer can do this week to avoid being letter seventeen.

Who FSVP applies to (and a few people who think it doesn't)

The Foreign Supplier Verification Program is part of the Food Safety Modernization Act. The rule sits at 21 CFR Part 1, Subpart L. Under section 805 of the FD&C Act and 21 CFR 1.500, an "importer" for FSVP purposes is the US owner or consignee of an article of food at the time of US entry. If there is no US owner or consignee at entry, the importer is the US agent or representative of the foreign owner. (21 CFR Part 1, Subpart L)

Three groups regularly assume FSVP does not apply to them and find out the hard way that it does.

The first group is small ethnic-food and specialty wholesalers. Looking at the 2026 cohort, the recipients include importers of coconut milk, fresh chayote, pacaya, mango, frozen seafood, pet chews, dairy products, melon seeds, and shelf-stable canned goods. Most are family-run operations that have been in business for years. None of that exempts them.

The second group is dietary-supplement importers. Supplements imported as finished products or as ingredients sit inside FSVP unless the importer is itself the manufacturer subject to 21 CFR Part 111 specifications. Even then, modified requirements apply under 21 CFR 1.511, which is still an FSVP. There is no version of "supplements are different" that makes the obligation disappear.

The third group is the "I just buy from a US wholesaler" group. If you take title at the port or you are listed as the US owner or consignee on the Customs entry, you are the FSVP importer for that shipment, even if a domestic broker sourced it for you. Drop-shipping arrangements that put a foreign exporter on one side of the deal and a US end-customer on the other have repeatedly produced FSVP violations for the company in the middle.

A short list of foods that are fully exempt from FSVP: juice and seafood already covered by HACCP regulations, food for research or evaluation in non-commercial quantities, food for personal consumption, alcoholic beverages from FDA-registered alcohol-producing facilities, and meat, poultry, and egg products under USDA jurisdiction. Everything else is in scope.

What FDA is actually checking

Reading 30 of these warning letters in a row makes the inspection priorities obvious. There is a hierarchy of findings, and most letters are issued at the top of the hierarchy because the facility never got past it.

The first thing an investigator asks for is the FSVP itself: a written program, food by food, supplier by supplier. If there is no document, the inspection ends quickly and the FDA Form 483a goes on the table.

If a written FSVP exists, the next checks are:

• A hazard analysis for each food, identifying biological, chemical (including radiological), and physical hazards requiring a control under section 418 (preventive controls) or section 419 (produce safety).
• An evaluation of each foreign supplier's performance and the risk posed by the food, considering the supplier's compliance history, the rigor of its food safety system, and storage and transport conditions.
• Written approval of each foreign supplier before importation begins, with documentation of the basis for approval.
• Supplier verification activities matched to the hazard. For hazards reasonably likely to cause serious adverse health consequences or death (SAHCODHA), the default is an annual onsite audit; sampling and testing or records review is acceptable for lower-risk hazards.
• Reevaluation at least every three years, or sooner when new information emerges about the food or supplier.
• A "qualified individual" who developed and oversees the FSVP, with documentation of education, training, or experience.

Each of those is its own potential 483a observation. A program that exists on paper but fails any of them is closer to compliance than no program at all, but the gap to a clean inspection can still be substantial.

The escalation path

The FSVP enforcement ladder is short and well-defined. Each rung is recoverable. The next one costs more.

FDA Form 483a, FSVP Observations. Issued at the close of the inspection, listing each violation. Not public. The importer has 15 working days to respond in writing. A complete, documented response (the actual FSVP, hazard analyses, supplier evaluations, verification records) usually closes the file. (What happens if you fail an FSVP inspection)

Warning Letter. Issued when the response is missing, late, or inadequate. Public, indexed by Google, and discoverable by any customer or partner doing diligence. Every 2026 FSVP warning letter we reviewed cited a 483a that was either ignored or answered without supporting documentation. The Espifresh letter is a clean example: the importer responded within three weeks, named a qualified individual, attached an FSVP standard operating procedure and a training certificate, and was still cited because no actual FSVPs for actual products were produced.

Import Alert 99-41. Detention without physical examination of human and animal foods imported from foreign suppliers by importers not in compliance with FSVP. (Import Alert 99-41) Goods covered by the alert are stopped at entry, can be refused admission, and must be re-exported or destroyed under FDA or Customs supervision at the importer's expense. Removal from the Red List requires submitting evidence of corrective action to the compliance officer named in the original letter.

Section 301(zz) prohibition. The act of importing without an FSVP that meets section 805 is itself a prohibited act under 21 USC 331(zz). That sets up the legal basis for refusal of admission under 21 USC 381(a)(3) and, in egregious cases, civil penalties or referral for criminal prosecution.

The Eaglelionton case shows how slowly this escalation can play out and how little time it actually takes when FDA decides to move. FDA inspected the Brooklyn site in May 2023 and again from late January through mid-February 2026. Between the two inspections the importer continued to bring in coconut milk and canned goods with no FSVP. The letter was dated about six weeks after the close of the second inspection. A return inspection that finds no progress is the typical trigger for Import Alert 99-41 placement.

What to do this week

If you run a small-to-mid-size import operation, the highest-leverage moves take a week of focused work, not a quarter.

Day one: name a qualified individual. This is the person who will own FSVP development and any future FDA conversation. Education, training, or experience is the standard. There is no FDA certification required. Document the basis in writing.

Days two and three: build the food and supplier matrix. List every food brought into the United States in the last twelve months, the foreign supplier for each, and the entry filer of record. Pull entries from your customs broker if memory does not match the paperwork. Almost every warning letter starts with FDA naming three to five specific products the importer could not produce a program for.

Days four and five: write hazard analyses and supplier evaluations. A two-page document per food is enough to start, identifying biological, chemical, and physical hazards reasonably likely to require a control. For high-risk categories like fresh produce, ready-to-eat foods, low-acid canned goods, and supplements in finished-dosage form, name SAHCODHA hazards and choose verification activities that match. The FDA Small Entity Compliance Guide is the cleanest plain-language reference. (FSVP Small Entity Compliance Guide)

Day six: collect supplier verification records. Recent third-party audit reports, certificates of analysis, FDA registration numbers, and any prior-year correspondence with the supplier about food safety. Missing records are the most common 483a observation after "no plan."

Day seven: store everything in one place. FSVP records must be retained for at least two years and produced upon request. A shared drive folder organized by food and supplier is acceptable. Email threads inside an inbox are not.

If you have multiple foods and limited internal capacity, the Very Small Importer modification at 21 CFR 1.512 is worth checking against. Importers below the VSI threshold qualify for reduced documentation. The threshold was set at the time of rulemaking at $1 million in human-food sales, with a separate $2.5 million threshold for animal food, and is adjusted annually by FDA for inflation. The modification is not an exemption: a written FSVP and a qualified individual are still required. What it removes is the supplier verification activity requirement, allowing the importer to rely on a written assurance from the foreign supplier instead.

The signal worth watching

The 2026 cohort tells us two things about how FDA is allocating FSVP attention.

The first is that follow-up inspections are landing on importers who were already on FDA's radar. Every importer who got a warning letter in April had been inspected at least twice before. Life Plus Style Gourmet (inspected 2022, 2023, and 2026), Eaglelionton (inspected 2023 and 2026), Espifresh (inspected July 2025 and January 2026), and The Wilatta Group (inspected 2019, 2022, and 2026). The pattern matches what FDA telegraphed when Import Alert 99-41 was created: identify importers who fail an inspection, give them a chance to fix it, then escalate when they do not.

The volume also clusters. On January 27, FDA posted four FSVP warning letters on the same day to Asli Foods, Zip Foods Importers, MG Group USA, and American Food Distributor. On March 3, three more posted simultaneously. On April 21, two. The pacing reads as an internal compliance docket being worked through in batches rather than a steady weekly drip.

The second is that the targets are not concentrated in one category or one region. The 26 FSVP letters since September 2025 cover produce wholesalers in California, ethnic-food distributors in Brooklyn and Atlanta, a pet treat importer, two dairy importers, supermarket-style operations in Puerto Rico and the Bronx, and a seafood importer. If the assumption inside the building is "FDA only goes after the big names," the data does not support it.

If you import food into the United States in any commercial quantity, the right question this week is not whether FSVP applies. It is whether the program on file would survive the same inspection that produced these 15 letters. The honest answer is the answer you would put in a 483a response.

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Policy Canary monitors the FDA for your specific products and ingredients, by name, by category, by foreign supplier. We surface every warning letter, recall, import alert, and rule that touches your business before it shows up in someone else's news cycle. See how it works for importers.

Sources

• 21 CFR Part 1, Subpart L — Foreign Supplier Verification Programs
• 21 CFR 1.502 — What FSVP must I have?
• Import Alert 99-41 — Detention Without Physical Examination
• FSVP Small Entity Compliance Guide (FDA)
• FSMA Final Rule on FSVP (FDA)
• What Happens if You Fail an FSVP Inspection — FDA Specialist
• Policy Canary regulatory database — 26 FSVP warning letters issued between September 2025 and April 2026, including warning letters to Eaglelionton Int'l Trading Co Inc, Espifresh Inc, Life Plus Style Gourmet LLC, The Wilatta Group Inc, Trangs Group USA Incorporated, A TO Z Distributor Inc, Supercan Bully Sticks LLC, R.R. Importaciones Inc, Las Americas Supermercado #2, East CK Trading Inc, Fidelity Melon Inc, The Great Smart African Food LLC, Asli Foods Inc, MG Group USA, American Food Distributor Inc, Zip Foods Importers Inc, Ocho Rios Atlanta Inc, East Bay Wholesale Corporation, V & L Produce Inc, Turkana Food Inc, Adja Khady Food Distribution Inc, Life Wholesale, Delicias Del Country USA Inc, Ever Rich Foods LLC, DingMoo LLC dba Dingman's Dairy, and Jalisco Fresh Produce Inc.