Latest News · October 19, 2026 · 7 min read
FDA Warns Ocean Pride Seafood Over Raw Tuna, Smoked Salmon
FDA's Sept. 11 letter (posted Oct. 13) says Ocean Pride Seafood's raw sushi-grade fish and smoked salmon are adulterated over HACCP and sanitation failures.
By Chris Carrillo · Reviewed by Armin Rad, Co-Founder & CTO, Aurascan · October 19, 2026
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FDA posted its warning letter to Ocean Pride Seafood, Inc. on October 13, 2026, after dating it September 11, 2026. The letter finds that the firm's ready-to-eat seafood, including raw tuna, raw salmon and vacuum-packed sliced smoked salmon, is adulterated for insanitary conditions. This is a company enforcement action, not an ingredient ban or a change to the seafood HACCP rule, and the letter does not disclose a recall or any illnesses.
Key takeaways
- FDA dated warning letter CMS #730154 on September 11, 2026 and posted it October 13, 2026.
- Inspectors found serious violations of the seafood HACCP regulation, 21 CFR Part 123, during the March 23 to April 1, 2026 inspection.
- Revised HACCP plans dated April 28, 2026 and submitted May 6, 2026 were judged inadequate.
- The letter cites a repeat monitoring violation from the November 14 to 19, 2019 inspection and no sanitation monitoring records from August 21, 2023 through April 1, 2026.
- The letter discloses no recall or illnesses.
What happened: FDA warning letter dated September 11, 2026, posted October 13, 2026
FDA's Human Foods Program issued warning letter CMS #730154 to Ocean Pride Seafood, Inc., addressed to CEO/Owner Thomas G. Moore at 2894 Bunsen Ave., Suite B, Ventura, CA 93003. The letter is dated September 11, 2026. FDA posted the letter to its warning letters page on October 13, 2026.
The action follows an FDA inspection of the Ventura facility conducted March 23 through April 1, 2026. According to the letter, the investigator found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123.
What changed: FDA's adulteration finding and the inadequate revised HACCP plans
According to the letter, FDA determined that the firm's ready-to-eat (RTE) seafood is adulterated under section 402(a)(4) of the federal Food, Drug, and Cosmetic Act, for insanitary conditions. The finding applies to the RTE products named in the letter's product list. The letter adds that, under 21 CFR 123.6(g), a seafood processor that fails to have and carry out a compliant HACCP plan makes its products adulterated.
The firm submitted revised HACCP plans dated April 28, 2026, and submitted them May 6, 2026. FDA judged them inadequate. According to the letter, the plans were missing pathogen and histamine hazards and temperature critical limits. One plan, titled 'HISTAMINE GROUP', lumped species together, and the corrective actions were incomplete. Separately, the letter says the firm did not carry out its listed monitoring for pathogen growth, scombrotoxin (histamine) formation and parasites in its RTE histamine-forming finfish.
FDA pointed the firm to its June 2022 guidance, Fish and Fishery Products Hazards and Controls, which the letter cites as a reference for hazards and controls.
Does the seafood HACCP rule change?
No change to 21 CFR Part 123 is reported in the sources cited here. The regulation is available in current form at the eCFR text of 21 CFR Part 123. The action applies the existing seafood HACCP regulation to one company, and the findings concern this firm's plans and records.
Who is affected: species, products, and the Ventura facility named in the letter
The letter lists the following as RTE seafood that FDA treats as adulterated:
- Aquaculture and wild caught raw tuna, and raw yellow tail tuna
- Aquaculture raw salmon
- Raw ono (wahoo), wild caught raw halibut, raw cod, raw seabass, raw mahi-mahi, raw snapper, raw trout, and raw amberjack loins
- Vacuum-packed sliced smoked salmon
- Vacuum-packed imitation crabmeat (surimi), scallops, and pasteurized canned crabmeat
- RTE live bivalves: live mussels, live oysters, and live clams
The grouping above follows the letter's product list. The letter also states that snapper, salmon, halibut, seabass, trout and cod are reasonably likely to contain parasites that must be controlled if eaten raw, but do not present a histamine hazard. The parasite concern and the histamine concern are therefore different findings for these species.
The letter is addressed to a single facility in Ventura, California. It does not disclose the retail brands, restaurants or retailers that received the products, or the distribution area. Because the letter does not say where the products were sold, it cannot show which stores or menus may be connected.
What causes histamine (scombroid) poisoning in tuna?
The letter lists raw tuna among the RTE seafood it treats as adulterated. It says the firm did not carry out its listed monitoring for scombrotoxin (histamine) formation in RTE histamine-forming finfish. The letter does not report a poisoning case or a measured histamine level in any tuna product, so this article does not describe any individual risk.
What it means for shoppers: labels, recalls, and what the letter does not say
The letter names no brand and discloses no recall. It reports no illnesses and does not describe any product sampling or laboratory results. It is a regulatory record of the firm's food safety system, and it does not identify specific packages for buyers to check.
A package label is limited in what it can show. Practical checks include:
- Look for a processor name or address and compare it with Ocean Pride Seafood, Inc., Ventura, CA, the company named in the letter.
- Check FDA's warning letters page and recall listings for later postings before drawing conclusions.
A label does not show a processor's HACCP plan or monitoring records, so it cannot answer whether a firm's controls were adequate.
Can vacuum-packed smoked salmon carry botulism risk?
The letter says the firm did not implement its listed monitoring for Clostridium botulinum growth and toxin formation in RTE sliced smoked salmon. That is a failure to carry out the firm's own monitoring, not a reported case of botulism, and the letter reports no illnesses. The letter does not report testing of any package, so it does not establish whether a specific package carried the organism or its toxin.
The background: the 2019 repeat violation and FDA's seafood HACCP framework
The letter describes the monitoring failure as a repeat violation from FDA's inspection of November 14 to 19, 2019. The earlier finding and the 2026 findings both concern monitoring that the firm had listed but did not carry out.
What is seafood HACCP?
21 CFR Part 123 is the seafood HACCP regulation, the rule that seafood processors follow when they run a hazard analysis and critical control point system. Under that framework, a processor identifies hazards, sets critical control points, establishes monitoring and corrective actions, and keeps records. The eCFR text of 21 CFR Part 123 sets out those requirements. The letter also cites FDA's June 2022 guidance, Fish and Fishery Products Hazards and Controls, as a reference for hazards and controls.
Sanitation findings: monitoring records and plant conditions
The letter reports no sanitation monitoring records from August 21, 2023 through April 1, 2026. It also reports no receiving monitoring records since November 23, 2022, and no cooler-temperature or ice records since December 31, 2022.
The letter describes conditions the investigator saw on March 23, 2026. An employee washed a fresh, gutted salmon on the floor over a trench drain with a water hose, and the same salmon was then moved to the processing table for filleting and deboning; it was not discarded. Mold and rust had built up on the ice machine, whose ice comes into direct contact with raw RTE tuna, salmon and ono. The investigator also saw personal food stored in a cooler and freezer, and live flying insects in the ice machine storage bin and the processing room.
What to watch next: FDA response deadlines and the firm's corrective actions
The letter asks the firm to respond in writing within 15 working days of receiving it. The response must include a revised HACCP plan and at least five consecutive production days of critical control point and sanitation monitoring records. The letter warns that failure to address the violations may lead to seizure, an injunction, or suspension of the firm's food facility registration.
The date the firm received the letter is not disclosed, so no calendar deadline is calculated here. Whether the firm has responded since the letter is also not disclosed. Readers can follow FDA's warning letters page for postings, and any later recall notice or follow-up letter would appear through FDA channels.
Related seafood and food-safety enforcement coverage on Aurascan
For other recent FDA actions, see Dreyer's Ice Cream Plant Gets FDA Warning Letter Over Listeria, FDA Warns Venezuelan Cheese Maker Over Roaches and No Safety Plan and FDA's 2025 Outbreak Report: 69 Incidents, 11 Advisories. For a seafood recall involving a different company, read Starfish Smoked Salmon Listeria Recall: Check Lot D080-148.
Packaged seafood such as smoked salmon and imitation crab carries an ingredient list worth reading. Scan the next one you buy with the Aurascan app to see what each ingredient is.
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Common questions
- Why did FDA send Ocean Pride Seafood a warning letter?
- FDA's letter cites serious violations of the seafood HACCP regulation, 21 CFR Part 123, found during an inspection from March 23 to April 1, 2026. According to the letter, FDA determined the firm's ready-to-eat seafood is adulterated under section 402(a)(4) for insanitary conditions.
- What is seafood HACCP?
- 21 CFR Part 123 is the seafood HACCP regulation. It requires processors to identify hazards, set critical control points, establish monitoring and corrective actions, and keep records.
- Can vacuum-packed smoked salmon carry botulism risk?
- The letter says the firm did not implement its listed monitoring for Clostridium botulinum growth and toxin formation in RTE sliced smoked salmon. It reports no illnesses and does not say whether any package tested positive.
- Did FDA recall any Ocean Pride Seafood products?
- The letter mentions no recall. It names the products FDA treats as adulterated, but it does not disclose a recall of any specific product.
- Does the letter name any stores or brands that sold these products?
- No. The letter does not disclose retail brands, restaurants or retailers that received the products, or the distribution area.
- Which raw fish does FDA say can contain parasites?
- The letter states that snapper, salmon, halibut, seabass, trout and cod are reasonably likely to contain parasites that must be controlled if eaten raw, but do not present a histamine hazard.
- Has Ocean Pride Seafood responded to the warning letter?
- Whether the firm has responded since the letter is not disclosed. The letter requires a response within 15 working days, including a revised HACCP plan and at least five consecutive production days of monitoring records.
Sources
- Ocean Pride Seafood, Inc. - 730154 - 09/11/2026 (FDA Warning Letter) (fda.gov)
- FDA Warning Letters and Compliance Actions (fda.gov)
- 21 CFR Part 123: Fish and Fishery Products (ecfr.gov)
- Fish and Fishery Products Hazards and Controls Guidance (June 2022 Edition) (fda.gov)
- Seafood HACCP and the FDA Food Safety Modernization Act: Guidance for Industry (fda.gov)
In this series
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