Ocean Pride Seafood, Inc.

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September 11, 2026

WARNING LETTER

Re: CMS #730154

Dear Mr. Moore:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 2894 Bunsen Ave., Suite B, Ventura, CA 93003-7682, from March 23, through April 1, 2026. During our inspection, the FDA investigator found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).

Based on FDA’s inspectional findings we have determined that your ready-to-eat (RTE) seafood products: aquaculture raw tuna, aquaculture raw salmon, wild caught raw tuna, raw ono (wahoo), wild caught raw halibut, raw yellow tail tuna, raw cod, raw seabass, raw mahi-mahi, raw snapper; raw trout, raw amberjack loins, vacuum-packed sliced smoked salmon, vacuum-packed imitation crabmeat (surimi), scallops, pasteurized canned crabmeat, live mussels, live oysters, and live clams are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Furthermore, in accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with 21 CFR 123.6 whenever a HACCP plan is necessary or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

You may find the Act, the seafood HACCP regulation, and the June 2022 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA’s home page at www.fda.gov.

At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your facility. You provided responses to the FDA-483 issued to you on April 1, 2026 and May 6, 2026. Your May 6, 2026, response included revised HACCP plans that are not adequate. We are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We address your response below.

Your significant violations of the seafood HACCP regulation are as follows:

1. You must implement the monitoring procedures that you have listed in your HACCP plans for “histamine group tuna, snapper, salmon, halibut, seabass, ono”, and “Scallops, Smk salmon ((b)(4))” to comply with 21 CFR 123.6(b).

Specifically, you have not implemented your monitoring procedures to control the following hazards:

• Clostridium botulinum growth and toxin formation for your RTE sliced smoked salmon; and
• Pathogen growth and toxin formation, scombroxton (histamine) formation, and parasites for your RTE histamine producing finfish.

This is a repeat violation from the FDA inspection conducted at your firm on November 14–19, 2019.

During the March 23 – April 1, 2026 inspection, the following monitoring deficiencies were observed:

• At receiving and storage of vacuumed packed smoked salmon, your firm did not implement the listed monitoring procedure of “(b)(4)” at the receiving Critical Control Point (CCP) and “(b)(4)” at the storage CCP.
• At receiving and cooler storage CCPs, for histamine producing finfish, your firm did not implement the listed monitoring procedure of “(b)(4) on the product.”
• You did not have monitoring records for the receipt of fishery products since November 23, 2022, and you did not have monitoring records documenting either the ambient temperature of the (b)(4) cooler or that ice completely surrounded RTE fishery products during refrigerated storage since December 31, 2022.

2. You must conduct or have conducted for you, a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption."

However, your firm’s revised HACCP plans submitted with your May 6, 2026 response, have not implemented controls for all hazards:

• Your revised HACCP plan for “HISTAMINE GROUP,” dated April 28, 2026, does not list the food safety hazard of pathogenic bacteria growth and toxin formation for your “Receiving” and “Cooler Storage sales” CCPs, and does not list the food safety hazard of scombrotoxin (histamine) for your “Cooler Storage sales” CCP. Additionally, your critical limits for preventive measures do not list temperature requirements that would significantly control these hazards. See Chapters 7 and 12 of the Hazards Guide.
• Your revised HACCP plan for “SHELLFISH,” dated April 28, 2026, does not (b)(4).
• Your revised HACCP plan for “Smoke salmon, Imitation crab meat ((b)(4),” dated April 28, 2026, does not list the food safety hazards of pathogenic bacteria growth and toxin formation and Clostridium botulinum toxin formation for your “STORAGE” CCP. Additionally, your critical limits for preventive measures do not list temperature requirements that would significantly control these hazards. The revised HACCP plan also lists parasites as a hazard at your “RECEIVING” CCP; however, parasites are not reasonably likely to occur in products that receive thermal processing. See Chapter 13 of the Guide.

3. You must have and implement a written HACCP Plan for each kind of fish and fishery product to comply with 21 CFR 123.6(b)(2). However, your “HISTAMINE GROUP” HACCP plan, dated April 28, 2026, submitted with your May 6, 2026, response, lists the following species: tuna, snapper, salmon, halibut, seabass, ono, trout, cod, mahi-mahi, and yellowtail.

Because you process different species of fish, intended to be cooked or consumed raw, your HACCP plans should be specific for those species of fish with the same process or species related hazards. Fish species such as snapper, salmon, halibut, seabass, trout, and cod, are reasonably likely to contain parasites, which must be controlled if the product is intended to be eaten raw by the consumer. However, these species do not present a histamine hazard.

4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). The corrective actions listed in your firm’s revised HACCP plans submitted with your May 6, 2026, response, are inadequate in the following respects:

• Your revised HACCP plan for “SHELLFISH”, dated April 28, 2026, lists a corrective action at the “Receiving shell Stock” CCP of: “1) (b)(4). 2) (b)(4). Make a corrective note.” Your corrective action should include the following steps: chill and hold affected product until a food safety evaluation of the cumulative time and temperature exposures is conducted with unsafe product being discarded, and correction for the cause of the deviation (e.g., repairing the cooler or conducting employee training).

Additionally, the listed corrective action at the “Cooler storage” CCP is “if product has a temp. (b)(4).” While discarding unsafe product is appropriate, the corrective actions should also list a correction to the cause of deviation (e.g., repairing the cooler or conducting employee training).

• Your revised HACCP plan for “Smoke salmon, Imitation crab meat ((b)(4)), past crab meat”, dated April 28, 2026, lists a corrective action at the “RECEIVING” CCP as: "If the product temperature Exceeds (b)(4), it must be refused. Write corrective action note." Your corrective actions should also list a correction to the cause of deviation (e.g., discontinuing use of the supplier until evidence is obtained that the identified handling practice has been corrected).

Additionally, the listed corrective action at the “STORAGE” CCP is “(b)(4)”. Your corrective actions should include the following steps: (b)(4). Your corrective actions should also list correction to the cause of deviation (e.g., repairing the cooler or conducting employee training).

5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with the current good manufacturing practice requirements in 21 CFR Part 117, Subpart B (CGMPs), and maintain records of your observations to comply with 21 CFR 123.11(b). However, your firm did not monitor the eight areas of sanitation to ensure compliance with the CGMPs. Your manager confirmed during the inspection that the last sanitation monitoring record was completed on August 21, 2023. No sanitation monitoring records were available for the period August 21, 2023, through April 1, 2026.

Additionally, the following insanitary conditions were observed during the inspection on March 23, 2026:

• An employee washing a fresh, gutted salmon on the floor over a trench drain using a water hose, the same salmon was then moved from the floor to the processing room table for filleting and deboning. The gutted salmon was not discarded.
• Mold and rust build up on the ice machine, which produces ice that comes into direct contact with raw RTE tuna, RTE salmon, and RTE ono.
• Personal food items being stored in the (b)(4) cooler and freezer.
• Live flying insects in the ice machine storage bin and in the processing room.

You should review the Sanitation Control Procedures for Processing Fish and Fishery Products guidance for sanitation procedures and monitoring.

Your response to this Warning Letter should provide your corrective actions and supporting documentation that includes a revised HACCP plan with CCP monitoring records and sanitation monitoring records for at least five consecutive production days to demonstrate implementation.

The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your facility complies with all requirements of federal law, including applicable FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Please notify FDA in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documentation. If you cannot complete all corrections within fifteen (15) working days, state the reason for the delay and the time frame within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your written response electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Bruce E. Taylor, Compliance Officer, at Bruce.Taylor@fda.hhs.gov. If you have any questions regarding this letter, you may contact Bruce E. Taylor, Compliance Officer, at Bruce.Taylor@fda.hhs.gov. Please reference CMS #730154 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program