Between January and May 2026, FDA issued four warning letters to US seafood importers citing 21 CFR 123.12, the importer-verification section of the seafood HACCP regulation. They are public, they are short, and read together they say something more specific than "FDA is looking at importers." Here is what is in them.
What are the four letters?
| Date | Importer | Products named | What FDA wrote |
|---|---|---|---|
| Jan 16 | New Hyde Park, NY | Yellow croaker, razor clam, frozen anchovy, granular ark, fish roe prawn paste | "You have not implemented an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation, as required by 21CFR123.12(a)(2)(ii)." |
| Feb 19 | Chicago, IL | Tilapia, frozen shrimp, frozen shrimp HOSO | Procedures "do not identify which affirmation step(s) you have chosen to implement" and "lack written specifications designed to ensure that imported shrimp and tilapia are not adulterated." A receiving record "was not signed and dated at the time of the activity." A repeat from a November 2022 inspection. "This response has been deemed inadequate." |
| Apr 15 | Boston, MA | Frozen aquaculture salmon fillets | "You do not have or have not implemented an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii)." An earlier inspection in June 2024 is noted. |
| May 26 | Houston, TX | Redacted | "You do not have or have not implemented written verification procedures, product specifications and an affirmative step" — "a repeat observation from the previous inspection conducted 08/28/2019 through 08/29/2019." |
Each letter links from FDA's warning-letter database, and each is worth reading in full; they run two to four pages. One more belongs alongside them. A November 20, 2025 letter to a Vernon, California firm, posted in May 2026, was mostly about the firm's own processing, but it also found that the firm "did not perform an affirmative step for fresh Salmon (Aquaculture) from Faroe Islands" and did "not maintain written import verification procedures, product specifications and an affirmative step" for that product. On September 15, 2026 that importer and that processor were added, as a pair, to Import Alert 16-119.
What do they have in common?
The blunt failure. Not one of the 2026 letters says the importer chose a step and ran it badly. Each says there was no affirmative step, or that the procedures did not say which step applied to which product. The Chicago letter adds two more absences: no written product specifications, and a record not signed and dated when the activity happened.
It is worth being precise about this, because the 2026 letters are sometimes described as FDA getting stricter about the content of verification, about specifications that miss a hazard the Fish and Fishery Products Hazards and Controls Guidance lists. That is a real finding, and FDA has made it. The clearest example is a May 2023 letter about tilapia specifications that did "not include parasite hazards" and did "not identify specific aquaculture drug hazards," where two resubmitted plans were rejected for the same omissions. But it is a 2023 letter. The 2026 letters are one tier below that: the file did not exist, or did not name a step for the product.
What are the three patterns underneath?
The unit is the supplier-product, not the importer. The Chicago importer had verification procedures. FDA's finding was that they did not "identify which affirmation step(s)" applied to the tilapia and the shrimp. The January letter lists five products; the November 2025 letter names one product from one processor. This is how FDA's own inspection program is built. Compliance Program 7303.844 has the investigator complete a separate Import Seafood HACCP Report, Form FDA 3502, "for each product-foreign processor-importer combination evaluated during the importer inspection." An importer with thirty products from twelve plants is thirty rows, and a file that is complete in general and silent on one row is, for that row, no file.
A §123.12 observation is the reason the next inspection comes. Three of the five letters cite an earlier inspection: 2019 in Houston, 2022 in Chicago, 2024 in Boston. This is not coincidence. Among the criteria the compliance program gives for choosing which importers to inspect is "reinspection of importers that had inadequate affirmative steps during their previous HACCP inspection in order to determine if they have adequately corrected previous deficiencies." A Form 483 observation on importer verification puts the firm on the list for the next cycle, and the Houston letter shows the cycle can be seven years long and still be called a repeat.
A response that describes corrections is not a response that documents them. The Chicago firm answered its 483. FDA's letter: "This response has been deemed inadequate." The Vernon firm answered three times, in April and July 2025; the warning letter followed in November, and the import-alert listing ten months after that. FDA's request in every letter is the same: a written response within fifteen working days "outlining the specific steps you have taken to correct" the violations, with documentation. The documentation is the response. A letter saying that procedures will be written is, on the evidence of these letters, read as confirmation that they have not been.
What did the letters not say?
They did not say any importer's product specifications missed a Guide hazard, or that a step was chosen and its evidence was stale, or that a plan held under step (d) was inadequate. Those findings exist in FDA's program, and the compliance program instructs investigators to record the last one on the 483 when a held plan "fails to list a significant health hazard identified with the product" in the Guide. But they are what an inspection finds in a file that exists. The 2026 letters are about files that did not.
That ordering is useful. The first thing an investigator will establish is whether there is a written procedure, a specification, and a named step for the product in front of them. Everything else is the second question.
What does this mean for a file?
For every product from every foreign processor, three things on paper, in English, dated when they were done:
- Written verification procedures that name the affirmative step for that product and that processor, not for the company in general. §123.12(a)(2).
- Product specifications for that product, written to the safety hazards, "designed to ensure that the product is not adulterated." §123.12(a)(2)(i).
- The step's evidence, whichever step it is: the lot records, the certificate and its expiry, the visit report, the plan and guarantee, the test results. §123.12(c), which points to §123.9 for signing, dating and retention.
None of this says whether a given file is adequate; that is a determination an investigator makes at the file, and FDA's letters are the record of what it looked like when they made it. What the 2026 letters do say, in FDA's words five times over, is what the first question is.
Citations: 21 CFR 123.9, 123.12. FDA warning letters dated November 20, 2025, January 16, February 19, April 15 and May 26, 2026, and May 18, 2023. FDA Compliance Program 7303.844, Import Seafood Products, Part II item B.2 and Part III item G. Import Alert 16-119, published September 15, 2026. Nothing here is legal advice. Where this piece and a letter differ, the letter is right and we would like to know.