Warning letters
None posted. As of September 17, FDA's warning-letter database shows no letter with a Seafood HACCP subject issued or posted since the May 26 letter to a Houston importer, which itself was posted July 14. That leaves the count for 2026 where it was: four seafood HACCP letters to importers, dated January 16, February 19, April 15 and May 26, every one of them citing 21 CFR 123.12 for the absence of an affirmative step. What those four have in common, and what they do not, is the subject of a separate guide.
FDA posts letters weeks after issuing them. A letter dated in September may still appear in October, and if one does it will be in the next edition.
Import Alert 16-120 — foreign processors
One processor was added to the Red List in September. Product from a listed processor is detained without physical examination at entry.
September 9 — Nagasaki Takara Syokuhin Co., Ltd., Kyoudomari Factory, Nagasaki, Japan. Frozen breaded squid tentacles, two product codes. FDA's listing: "21 CFR 123.6(a) and (b) - Failure to conduct a hazard analysis and have and implement a HACCP plan, and 21 CFR 123.11(b) - failure to monitor sanitation conditions."
This is a different kind of entry from August's three. Those were plans FDA had read and found short — a missing hazard, a missing critical limit, a missing corrective action. This listing says there was no hazard analysis and no plan to read. For an importer holding affirmative step (d) for this processor, an English copy of the processor's HACCP plan plus a written guarantee, that is worth sitting with: whatever document is in the file under (d), FDA's position as of September 9 is that the processor has not conducted a hazard analysis or implemented a plan.
Removals: none shown. The alert page lists what is on the Red List, not what has come off it.
Import Alert 16-119 — importer and processor pairs
One pair was added on September 15, and it is the most instructive entry on either alert this year.
September 15 — Bakkafrost Processing, Glyvrar, Faroe Islands, paired with a Vernon, California importer. Fresh ready-to-eat salmon, aquaculture, under three product codes including cold-smoked. The alert lists the pair twice, once under the Faroe Islands and once under the United States, as it does for every combination.
The importer is the firm that received FDA's November 20, 2025 seafood HACCP warning letter, posted May 5, 2026. That letter was mostly about the firm's own processing — a fresh tuna plan with no critical control point for histamine, inadequate critical limits, missing receiving records. But it also said this: "your firm did not perform an affirmative step for fresh Salmon (Aquaculture) from Faroe Islands. Your firm does not maintain written import verification procedures, product specifications and an affirmative step for fresh and RTE Salmon manufactured by Bakkafrost Processing in Faroe Islands."
So the chain, in one firm, with dates: inspection March 26 to April 15, 2025; three written responses to the FDA 483 in April and July 2025; a warning letter on November 20, 2025; and the pair on 16-119 on September 15, 2026, seventeen months after the inspection and ten months after the letter.
Import Alert 16-119 is "Detention Without Physical Examination of Fish and Fishery Products for Importer and Foreign Processor (Manufacturer) Combinations." A pair is listed when, in the alert's words, the division "determines that the importer has failed to meet HACCP verification requirements for a specific product and foreign processor." The processor's own plan is not what is at issue; the listing is about the importer's file. The alert lists combinations, so the entry covers this importer and this processor, not the processor's other customers. Removal is by petition, with evidence that the importer now has and implements verification procedures under §123.12 for that product and processor.
Removals: none shown.
What this means for your file
The 16-119 entry is what "no affirmative step" costs, spelled out. A well-known processor is now named on an FDA detention list, next to its customer, because the customer's file for that product had nothing in it. The processor's plan was never the finding. If a supplier asks you what §123.12 has to do with them, this entry is the answer: their name goes on the alert with yours.
The finding was procedural, and the fix is procedural. Written verification procedures; product specifications for the product; one affirmative step, named, per supplier-product; records in English, signed and dated when the step was performed. That is the whole of what the November letter said was missing for the salmon. None of it requires reading a plan against the Guide. It requires the row to exist.
The 16-120 entry is the other half. Where the file does hold a plan under step (d), the plan is what FDA reads. A processor listed for having no hazard analysis and no plan is a processor whose (d) cannot be adequate. If you buy from the Nagasaki plant, look at that row this month, and at what the step was.
Ten months is the clock to plan around. Not fifteen working days. The November letter gave the firm fifteen working days to respond; the alert came ten months later. A warning letter is not the end of the sequence, and a response that describes corrective actions without documenting them does not stop it: FDA's February letter to a Chicago importer said of exactly such a response, "This response has been deemed inadequate."
Sources, all read September 17, 2026: FDA warning-letter database, filtered on "seafood"; FDA warning letter to Aaa International Seafood Corp., November 20, 2025; Import Alert 16-119 (published 09/15/2026); Import Alert 16-120 (published 09/15/2026); FDA Compliance Program 7303.844. Keelsure is a documentation tool. It does not determine or certify compliance with any regulation, and it is not legal advice.