The short answer
FDA keeps sending warning letters to U.S. food importers under the Foreign Supplier Verification Program (FSVP) rule. In the 2026 letters we reviewed, the most common charge was the most basic one: the importer had no FSVP at all for some or all of the foods it imported (21 CFR 1.502(a)). The consequence is serious: FDA can put the importer’s foods on Import Alert 99-41, which means shipments are detained at the port without examination.
This matters to exporters too. Your product can be perfectly safe and still be held at the border because your U.S. buyer has no FSVP.
Who is the “FSVP importer”?
The U.S. owner or consignee of the food when it enters the United States. If there is no U.S. owner or consignee at entry, it is the U.S. agent or representative of the foreign owner, who must confirm the role in a signed statement of consent. The customs broker is not the FSVP importer just because it files the entry.
What FDA cited in 2026
FDA publishes its warning letters online. Three FSVP letters from 2026 show the pattern clearly:
| Letter date | What FDA found | Regulation cited |
|---|---|---|
| April 23, 2026 | No FSVP for an imported vegetable product. The importer also had not answered the Form FDA 483a issued after the inspection. | 21 CFR 1.502(a) |
| June 26, 2026 | No FSVP for any imported food, including sesame, cheese and baklava. | 21 CFR 1.502(a) |
| July 20, 2026 | No FSVP for 20 products (snacks, coffee, noodles, biscuits, canned fruit and beans in syrup). For canned low-acid foods, no check that the supplier followed the U.S. canning rules. | 21 CFR 1.502(a) and 1.502(b)(1) |
Each letter gave the importer 15 working days to reply in writing and warned that its foods could be detained without physical examination under Import Alert 99-41.
The 7 mistakes behind most FSVP problems
The FSVP rule (21 CFR part 1, subpart L) is a list of things the importer must do and document. These are the gaps that lead to Form FDA 483a observations and warning letters:
- 1No written FSVP for each food and supplier (§ 1.502)Many importers assume their supplier’s certificate or a broker’s paperwork is enough. It is not. The importer needs its own written program for each food from each foreign supplier.
- 2No qualified individual (§ 1.503)The FSVP must be developed and its activities carried out by a qualified individual — someone with the education, training or experience to do the work, who can read the supplier’s documents.
- 3No written hazard analysis (§ 1.504)The importer must identify the known or reasonably foreseeable hazards for each food — biological, chemical and physical — and decide which need a control.
- 4No supplier evaluation and approval (§ 1.505)Before importing, the importer must evaluate the supplier’s performance and the risk of the food, including the supplier’s FDA compliance history, and approve the supplier in writing.
- 5No verification activities (§ 1.506)Examples are a third-party audit, sampling and testing, or a review of the supplier’s food safety records. The importer must decide which activity fits the hazard and how often to do it.
- 6Wrong or missing importer identification at entry (§ 1.509)For each line of each entry, the FSVP importer’s name, email address and unique facility identifier (a D-U-N-S number is accepted) must be sent electronically to U.S. Customs and Border Protection.
- 7No records, or records FDA can’t get (§ 1.510)FSVP records must be signed, dated and made available to FDA on request. If FDA asks and nothing comes back, that is a violation in itself.
What happens after a warning letter
A warning letter is FDA’s formal notice that it considers the importer to be in violation. In practice:
- The importer must answer in writing within 15 working days, explaining what it has fixed and how it will stop it happening again.
- FDA can add the importer to Import Alert 99-41. From then on its shipments can be held at the port until it shows its FSVP is adequate.
- FDA can refuse admission of the food under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act.
- Warning letters are public. U.S. buyers, retailers and Amazon can see them.
Example: one supplier, one simple fix
A small U.S. importer brings in rice snacks from Thailand and coffee from Vietnam. It has the suppliers’ HACCP certificates, but no hazard analysis, no supplier approval and no verification plan of its own. That is “no FSVP” in FDA’s eyes. Writing an FSVP for each supplier — hazard analysis, approval, a verification activity and a reevaluation date — is usually enough to close the gap before FDA finds it.
How to avoid an FSVP warning letter
- 1List every food and every supplierInclude “small” lines like sauces, snacks and ingredients bought for the shop. Each one needs to be covered.
- 2Write the FSVP before the first shipmentHazard analysis, supplier evaluation and approval, verification activity and corrective action procedures.
- 3Make sure the right importer is named at entryCheck that your broker sends the correct FSVP importer name, email and D-U-N-S number on every entry line.
- 4Reevaluate at least every 3 yearsAnd sooner if you learn of a new hazard, a supplier problem or an import alert.
- 5Keep records readyFDA FSVP inspections often start with a records request. Keep everything signed, dated and easy to send.
FSVP program development from $400 per supplier. Or Orionex can act as your FSVP importer: $600 per year or $80 per shipment.
Frequently asked questions
What is the most common FSVP violation?
Not having an FSVP at all for one or more imported foods, cited under 21 CFR 1.502(a). In the 2026 FSVP warning letters we reviewed, it was cited every time.
What is Form FDA 483a?
It is the form an FDA investigator gives the importer at the end of an FSVP inspection, listing the problems found. Answer it quickly and in writing — one 2026 warning letter noted that the importer never replied to its 483a.
Does a GFSI or HACCP certificate replace an FSVP?
No. A supplier’s certificate or audit report can support your verification activities, but the importer still needs its own hazard analysis, supplier approval and records. See GFSI certificates and FSVP.
How long does an importer have to answer an FSVP warning letter?
The 2026 letters asked for a written response within 15 working days of receipt, with an explanation and timeline for anything that cannot be fixed in that time.
Sources
- FDA warning letter CMS 728463 (April 23, 2026)
- FDA warning letter CMS 731741 (June 26, 2026)
- FDA warning letter CMS 734615 (July 20, 2026)
- FDA — FSVP Small Entity Compliance Guide
- Federal Register — FSVP final rule (November 27, 2015)
Warning letters and regulation sections checked against FDA sources on November 11, 2026. This article is general information, not legal advice.