WARNING LETTER

Ocean Group Inc. MARCS-CMS 715467 — March 03, 2026

Delivery Method:: VIA Electronic Mail
Product:: Food & Beverages

Recipient:: Ocean Group Inc.; 1100 S Sante Fe Ave
Los Angeles, CA 90021
United States; jason@oceanfreshinc.com

Issuing Office:: Human Foods Program; United States

March 3, 2026

Re: CMS # 715467

Dear Mr. Kim:

The United States Food and Drug Administration (FDA) inspected four (4) of your Ocean Group seafood processing facilities, during a period from May 2025 through September 2025 (exact dates are listed below). FDA initiated an inspection at the Los Angeles facility as a compliance follow-up to the previous Warning Letter issued to you on April 17, 2024, and further expanded the inspection scope after a surveillance inspection at your Oceanside facility found similar sanitation deficiencies.

We are issuing this letter to you as the CEO of the corporation responsible for the facilities (i.e., referenced in this letter as your “facility” or “facilities”), because we found serious violations during our inspections of these facilities. During these inspections, FDA investigators found significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facilities. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your Los Angeles, CA, Las Vegas, NV, and Dallas, TX facilities. At the conclusion of the inspections, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing the violations found at each of your facilities.

Based on FDA’s inspectional findings and the analytical results for samples collected from your Los Angeles, CA, Las Vegas, NV, and Dallas, TX production environments, we have determined that the ready-to-eat (RTE) salmon and tuna processed in these three facilities 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 become contaminated with filth or rendered injurious to health.

Additionally, 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 this section 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 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your ready-to-eat (RTE) raw tuna and salmon processed at all four facilities are adulterated within the meaning of section 402(a)(4) of the Act You may find the Act, the seafood HACCP regulation, and the June 2022 Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

We are issuing this letter to advise you of FDA’s concerns with regard to four of the inspected facilities. This letter contains detailed information describing the inspectional findings, as well as your purported corrective actions taken at each of the facilities. Furthermore, FDA has determined that a Regulatory Meeting would be beneficial to discuss your firm’s corrective actions.

Facilities Inspected
FDA inspected the following four seafood processing facilities located throughout the country:

1. Los Angeles- located at 1100 S Sante Fe Ave, Los Angeles, CA 90021 conducted from June 24, 2025 through July 16, 2025, which processes RTE salmon and tuna. We acknowledge receipt of your responses dated July 11, 18, August 11, 18, and 26, 2025, which include a description of the corrective actions taken by your firm.

2. Las Vegas- located at 4630 W Post Road, Ste 105, Las Vegas, NV from August 25 through September 12, 2025, which processes RTE salmon and tuna. We acknowledge receipt of your responses dated October 9 and 29, 2025, which include a description of the corrective actions taken by your firm.

3. Dallas- located at 10600 Boomer Cir, Dallas, TX 75238 conducted from September 8 through September 17, 2025, which processes RTE salmon and tuna. We acknowledge receipt of your responses dated October 24 and November 14, 2025, which include a description of the corrective actions taken by your firm.

4. Oceanside- located at 1830 Ord Way, Oceanside, CA 92056 conducted from May 12 through May 28, 2025, which processes RTE salmon and tuna. We acknowledge receipt of your responses dated June 10, 2025 with additional photographs on August 21, 2025, which include a description of the corrective actions taken by your firm.

Pathogen Findings:
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism can grow and survive, and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening, illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.

Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementation of the hygienic practices necessary to control this pathogen. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive, and to apply controls or take corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and to prevent the organism from being re-established in such sites.

FDA’s analysis identified the following:

Los Angeles, CA

In 2025, (b)(4) out of (b)(4) swabs were positive for L. monocytogenes. The swabs were collected from non-food contact surfaces, including a hose handle, the bottom surface of a table, wheels of racks or other tables, and wooden broom bristles.
In 2024, (b)(4) out of (b)(4) swabs were positive for L. monocytogenes. The swabs were collected from a food contact surface (a cutting board) and a non-food contact surface drain in the processing room.
In 2023, (b)(4) of (b)(4) swabs were positive for L. monocytogenes. These swabs were collected food contact surfaces, such as a white cutting board and the interior of a grey plastic bin used to process RTE salmon and non-food contact surfaces.

The presence of the same strain of L. monocytogenes within that facility across multiple years is indicative of a resident pathogen. Whole genome sequencing (WGS) conducted on the (b)(4) L. monocytogenes isolates obtained from the 2025 FDA environmental swabs determined these isolates match isolates collected from your facility in 2023 and 2024 and a clinical isolate from an ill person in 2022. The presence of the same strain of L. monocytogenes that has caused illness across three different processing environments over multiple years suggests that strain has been within one or more of your facilities since at least 2023.

The recurring presence of L. monocytogenes in your Los Angeles, CA facility demonstrates that your sanitation procedures have been inadequate to effectively control pathogens in your facility and prevent contamination of food. It also demonstrates that your previous corrective actions were inadequate.

In your responses received July 11, 2025, August 11, 18 and 26, 2025 to these findings, you provided corrective actions that describe deep cleaning and sanitation, hiring of a third-party professional, industrial grade cleaning service to deep clean and sanitize the operating environments twice a month in addition to your daily deep clean. Your response also provided your own environmental sampling from (b)(4) samples, which showed negative results for Listeria spp., a technical report provided by your third-party cleaning service, environmental monitoring procedure, and root cause analysis.

Given the repeat history of the same strain of L. monocytogenes in your processing environments and most recent inspectional findings at the Los Angeles facility, we continue to be concerned about your ability to control L. monocytogenes within this facility.

Las Vegas, NV
FDA laboratory analysis of environmental swabs collected at your Las Vegas, NV facility, on August 27, 2025, confirmed that (b)(4) out of (b)(4) swabs were positive for L. monocytogenes. The swabs were collected from the top of a cutting board, on handles and a hook for blue hoses, on a drain, on a wall, and on the table leg of a fillet table.

WGS conducted on the (b)(4) L. monocytogenes isolates obtained from the 2025 FDA environmental swabs of your Las Vegas facility showed that the isolates belonged to a single strain that match (b)(4) clinical isolates from ill people and environmental isolates collected from your Los Angeles facility in 2023 and 2024.

We received your response to the Las Vegas sample findings on October 9 and October 29, 2025, in which you provide a root cause analysis with a determination that lack of cleaning and sanitation for transportation trucks by a third-party then the lack of hygiene and safety when processing the product resulted in the spread of L. monocytogenes from your Los Angeles facility to your Las Vegas facility. In your “(RCA) Root Cause Analysis Report” dated September 26, 2025, you listed corrective actions, including information that equipment, tools, and other contaminated sources were discarded and replaced, employee training, testing results from two drain swabs that led you to conclude that the Las Vegas facility is Listeria-free, and third-party cleaning services. In addition, you identified that the company “needs to make a radical change on the company culture / education and training staff / enforcement of safety to the company.” However, your response did not include supporting documentation for substantial changes to food safety culture and training such as improved sanitation control procedures and training material with frequency of training.

Dallas, TX
FDA laboratory analysis of environmental swabs collected at your Dallas facility on September 15, 2025, confirmed that (b)(4) of the (b)(4) swabs were positive for L. monocytogenes. These swabs were collected from hose handles, floor drains, an ice shovel handle, an exterior door flap to your cooler, the wheel of a pallet jack, and various sections of the floor in your staging room.

WGS of the (b)(4) L. monocytogenes isolates obtained from the 2025 FDA environmental swabs of your Dallas facility determined there were three clusters for the isolates as follows.

1. Isolates from (b)(4) of the positive environmental swabs from the Dallas facility match environmental sample isolates from your Las Vegas facility collected in 2025 and Los Angeles facility collected in 2023 and also match four clinical isolates from ill people collected between 2017 and 2023.

2. An isolate from (b)(4) of the positive environmental swabs from the Dallas facility matches (b)(4) clinical isolates collected from ill people in 2013 and 2014.

3. An isolate from (b)(4) of the positive environmental swabs from the Dallas facility matches (b)(4) isolates from food samples collected in 2008, 2010 and 2011 by the Canadian Food Inspection Agency (CFIA).

Your response received October 24, 2025, states you have hired a professional cleaning company to provide training on using chemicals to “eradicate Listeria” and you have continued to search for a laboratory to perform Listeria testing and sample affected areas. You also stated (b)(4). Additionally, your “(b)(4)” dated October 20, 2025, mainly identified lack of employee training as a root cause and listed corrective actions taken such as discarding equipment and tools, fixing of walls and floors, updates to record and logs, and training. However, no environmental monitoring procedure and no documentation to support the implementation of these corrective actions was provided.

Based on the above listed Listeria monocytogenes findings, inadequate corrective actions and lack of supporting documentation at all these facilities, we remain deeply concerned for your ability to implement and maintain sanitation controls for L. monocytogenes.

Seafood HACCP (21 CFR Part 123)
Your significant violations were as follows:

Sanitation conditions and practices

1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice (CGMP) requirements under 21 CFR Part 117, subpart B that are appropriate to your plant and food products (21 CFR 123.11(b)). However, your firm did not monitor the following conditions and practices with sufficient frequency to ensure cGMP compliance, as evidenced by the following observations by FDA investigators at your facilities where you process raw, RTE salmon and tuna:

a. Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments, as required by 21 CFR 123.11(b)(2):

i. Cutting boards used to process raw RTE tuna and/or salmon were discolored and had cuts, scratches, cracks and/or crevices at your Oceanside facility on May 12 through 15, 2025, at your Los Angeles facility on June 24, 2025, and at your Las Vegas facility on August 27, 2025. Additionally, one of the cutting boards swabbed at your Las Vegas facility tested positive for L. monocytogenes from a swab collected on August 27, 2025, and one of the cutting boards at the Oceanside facility tested positive for L. innocua in a swab collected on May 13, 2025.

ii. At your Oceanside facility from May 12 through 15, a white bin used to hold raw RTE salmon and ice before descaling was discolored with pink, brown, and black residue on the interior and exterior surfaces. After production on May 13, 2025, the bin was moved outside to allow ice to melt and then the bin was used the next day to again hold salmon and ice. Also, at the Oceanside facility from May 12 through 15, 2025, two bins used to hold ice used for cooling raw RTE fish were deeply scratched with dark brown residue within the scratches and other food residue (e.g., fish scales) adhering to surfaces. Your Vice President/COO of the Oceanside facility stated (b)(4).

iii. At the Los Angeles facility on June 25, 2025, a plastic ice pallet container was damaged with a cracked wall on the inside of the container exposing ice to its insulation, a material that cannot be properly cleaned and sanitized.

iv. At your Las Vegas facility on August 25 through 27, 2025, blue ice shovels had frayed edges, cracks, and crevices.

v. Employee aprons, which come into contact with raw, RTE fish during processing, were not kept clean or in good condition.

1. At your Oceanside facility on May 13, 2025, employee aprons were observed to be visibly worn and discolored during processing. However, your “(b)(4)” was clean and in good repair on May 13, 2025. Also, on May 14, 2025, after production, an employee was observed to drape an apron across a bush outside the facility and on May 15, 2025, after production, employee aprons were stored against a wall visibly soiled with food residue. Additionally, a swab collected from employee apron collected on May 13, 2025 was positive for Listeria innocua.

2. At your Las Vegas facility on August 25 through 27, 2025 employee aprons were discolored and visibly soiled and specifically on August 25, 2025, employees were washing and rinsing aprons directly on the production floor, where pooling water and trash were present, then were observed standing on the aprons with production boots during sanitizing. However, your “(b)(4)” was clean and in good repair on August 27, 2025.

3. At your Los Angeles facility on June 25, 2025, employees were using hoses to rinse their aprons of food debris which created splash onto the filleting tables. Employee aprons were observed to contact the fillet table leg and the wrapping table leg which were both found to have L. monocytogenes present in swabs collected on June 24, 2025.

vi. Food contact surfaces were not adequately cleaned and sanitized during sanitation. On August 25, 2025, after post-operation daily cleaning at the Las Vegas facility, the tuna ice table (“tuna bed”) still had fish bones. Additionally, your “(b)(4)” document dated August 25, 2025, was signed and verified as being scrubbed, rinsed, and sanitized for the tuna bed.

b. Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, as required by 21 CFR 123.11(b)(3):
i. Employees did not wash their hands and change their gloves after touching insanitary objects and prior to returning to work with raw RTE fish and/or handling food contact surfaces. Insanitary objects include:

1. Blue plastic crates, bins and/or insulated foam boxes that were previously in contact with the floor at the Oceanside facility on May 12 and 13, 2025, and at the Los Angeles facility on June 25 and 26, 2025;

2. The handle of a pallet jack that was also used by an employee from the cooler at the Los Angeles facility on June 26, 2025;

3. Trash, fish scraps, and bones off the ground and out of floor drains at the Las Vegas facility on August 25, 2025;

4. Face masks, glasses, and/or personal clothes (e.g. visibly soiled hat) at the Las Vegas facility on August 25 through 27, and on September 11, 2025;

5. Hose handles that had fallen to the floor at the Las Vegas facility on August 26, 2025, which were swabbed on August 27, 2025, and tested positive for L. monocytogenes; and

6. A paper towel roll that had fallen to the floor at the Dallas facility on September 8, 2025;

7. In addition, on June 26, 2025, at your Los Angeles facility, an employee filleted raw RTE salmon, exited the Fillet Room while wearing a steel chain glove to dispose of broken Styrofoam boxes outside the facility, and then returned to the Fillet Room and sanitized hands with the steel chain glove in the hand dip without washing. The steel chain glove had gaps that allow debris to accumulate. Sanitizing equipment without cleaning and removing fish protein debris will render the sanitizer in the hand dip ineffective.

ii. Plastic or vinyl curtains were a source of contamination.

1. At your Oceanside facility on May 12, 2025, employees transported insulated boxes containing salmon through vinyl curtains that were worn, discolored with dark residue, and not cleaned during May 12 through 14, 2025. The employees touched the boxes, then the RTE salmon fillets without washing or sanitizing hands or changing gloves. Employees, pallet jacks, and product containers passed through these vinyl curtains when moving from the Cooler to the Fillet Room.

2. At your Los Angeles facility on June 25, 2025, employees transported a large plastic ice pallet container filled with ice through plastic curtains into the Display/Staging Room in front of raw RTE tuna. The bottom of the plastic curtains came into contact with the ice, which was then shoveled into boxes of raw RTE tuna. The bottom of the plastic curtains also came into contact with employees' aprons, boots, and other pallets.

3. At your Las Vegas facility on August 25 to 27, 2025, RTE salmon and tuna and human by-product intended for animal food (i.e., cat food) came into direct contact with plastic curtains at the fillet room entrance. Employees also touched the plastic curtain with the same gloved hands that also handled raw, RTE salmon and tuna. These plastic curtains were found to have L. innocua present in an environmental swab collected on August 27, 2025, and they are not monitored or documented on either Daily Sanitation Control or Daily Sanitation Audit Form.

iii. Hoses were a source of contamination.

1. At your Oceanside facility on May 12, 2025, a water hose with a spray nozzle in the Fillet Room hung directly above a fillet table in direct contact with RTE salmon fillets. Employees used the hose to rinse food and food contact surfaces with pressurized water throughout production, in a manner that caused the hose to touch the floor multiple times, including the section that had previously touched the RTE salmon. The hose surface that came into contact with the RTE salmon showed black discoloration and was only cleaned and sanitized at the end of the production day.

2. At your Dallas facility on September 9, 2025, employees were using hoses while processing raw salmon and tuna, then storing the hose handles on the side of blue plastic bins, which held waste materials.

3. At your Los Angeles facility on June 25 and 26, 2025, employees were holding hose handles and using the hoses to spray water on raw RTE salmon, table tops and legs, aprons, gloves, and Styrofoam boxes. Employees returned to handling raw RTE salmon without washing and sanitizing their hands. Two hose handles were found to have L. monocytogenes, L. innocua, and L. welshimeri present from swabs collected on June 24, 2025.

iv. Tools used for cleaning were not appropriate or maintained.

1. At your Oceanside facility on May 13, 2025, two handheld squeegees used to remove water from cutting boards and tables in the Fillet Room were visibly worn with black discoloration along the wiper edges.

2. At your Los Angeles facility, employees used a wooden broom to push dirty water and debris on the floor toward the drain and to scrub the walls and tables with soap. The bristles of the wooden broom in the (b)(4) corner of your fillet room were swabbed on June 24, 2025, and was found positive for L. monocytogenes.

3. At your Las Vegas facility on August 25 to 27, 2025, ice was packed in bags, which came into contact with employees’ visibly soiled aprons and/or personal clothes, then were stored on an apparently soiled Styrofoam container or other soiled surfaces in the fillet room and warehouse. These ice bags were stored directly on raw RTE tuna in the fillet room.

4. At your Las Vegas facility on August 25, 2025, a descaler was in direct contact with the wall, and in direct contact with raw, RTE salmon on August 26, 2025. The investigator did not observe the yellow back of the descaler get a full wash, rinse and sanitize on August 25 or 26, 2025. The section of the wall was swabbed on August 27, 2025, which found L. monocytogenes.

c. Maintenance of hand washing, hand sanitizing, and toilet facilities, as required by 21 CFR 123.11(b)(4):

i. At your Oceanside facility, the hand washing station did not have hand sanitizer available for use. Further, the investigator did not observe employees washing hands or using hand sanitizer at any time during production from May 12 through 14, 2025. This lack of hand sanitizer was not reflected in your (b)(4)” for May 12 through 14, 2025, which was check-marked for adequate supply with water, soap, paper towels and sanitizer at the handwashing and sanitizing facilities.

ii. At your Las Vegas facility on August 25, 2025, the only handwashing sink in the fillet room did not have soap.

d. Protection of food, food packaging material, and food contact surfaces from adulteration with condensate, and other chemical, physical, and biological contaminants, as required by 21 CFR 123.11(b)(5):

i. Dripping condensate at multiple facilities.

1. At your Oceanside facility on May 15, 2025, condensate dripped from the metal rack directly above and onto the exposed ice covering raw RTE tuna stored in the cooler.

2. At your Los Angeles facility on June 25 and 26, 2025, condensate dripped from the air conditioning unit directly onto exposed RTE salmon that was being wrapped for distribution. The air conditioning unit was not cleaned or sanitized.

ii. Employee handling of water with gloved hands and/or hoses resulted in backsplash and/or aerosolized water from wooden pallets, Styrofoam boxes and other insanitary surfaces, including the floor, onto employee’s aprons and gloves, exposed raw RTE fish, and/or open Styrofoam boxes with blue lining. This was observed at your Oceanside facility on May 12 through 14, 2025, at your Los Angeles facility on June 25 and 26, 2025 and at your Las Vegas facility on August 26 and 27, 2025.

e. Proper labeling, storage, and use of toxic compounds, as required by 21 CFR 123.11(b)(6):

i. You did not follow sanitizer instructions for use and/or your sanitation operating procedures at multiple facilities, including at your Oceanside facility on May 12, 2025, your Los Angeles facility on June 25, 2025, and at your Las Vegas facility on September 11, 2025.

1. At your Las Vegas facility, an employee stated (b)(4). Employees then used this solution, which measured between (b)(4) ppm on the cutting boards later used to cut RTE salmon and tuna and on the gray ice bin used to store ice for the tuna tables.

2. At your Oceanside and Las Vegas facilities, the label for the concentrated Germicidal Bleach and chlorine sanitizing solution, respectively, did not include instructions for sanitizing food contact surfaces. These solutions were used to clean food contact surfaces.

ii. Your “(b)(4)” did not include a section to verify the concentration of sanitizers, or did not accurately reflect sanitizer concentrations.

1. At your Oceanside facility on May 12, 2025, your “(b)(4)” but there is no section on your “(b)(4)” to verify the concentration of chlorine; the investigator found that employees were not measuring the amount of concentrated hypochlorite bleach added, and used a chlorine sanitizer test strip that indicated a concentration above the maximum reading of 1000 ppm.

2. At your Oceanside facility on May 12, 2025, and at your Los Angeles facility on June 25, 2025, the quaternary ammonium sanitizer in spray bottles or used in hand dips measured above (b)(4) ppm, but the “(b)(4),” for both facilities which list that the concentration should be “Quat<200,” were both check-marked as verified for both days.

As noted above, non-human pathogenic Listeria spp. were found in all four of your facilities, including Listeria innocua, Listeria welshimeri, and Listeria seeligeri. Findings of non-human pathogen Listeria spp. within the processing environment are an indicator of inadequate sanitation and conditions that can support growth of the human pathogen, L. monocytogenes.

We have reviewed your responses to the above listed sanitation deficiencies from the following facilities and find them to be inadequate, as further discussed below.

Oceanside, CA
We reviewed your response received on June 10, 2025, to the above listed sanitation deficiencies found during the Oceanside facility inspection and find the response to be inadequate. Your response stated (b)(4). However, you did not provide the supporting documentation for these actions such as records that provide the specifics on the cleaning and sanitizing done such as where, what, when, how, and who. Also, the response did not include employee training material or employee training records. Furthermore, your response did not include corrective actions that are intended to prevent recurrence such as sanitation control procedures that are detailed with increased frequency of monitoring to ensure implementation and compliance with 21 CFR 123.11.

Los Angeles, CA
We reviewed your responses received on July 11 and 18, 2025, August 11, 18 and 26, 2025, to the above listed sanitation deficiencies found during the Los Angles facility inspection and find the responses to be inadequate. Your response stated that you replaced a cutting board, table, brooms, bins, roller carts and hose handles. You also stated (b)(4). You trained employees, adjusted the strength of hoses’ water pressure so that over spray does not occur, and have updated the sanitation form to include an area to write the exact reading of the sanitizer concentration. You indicated that the refrigeration unit was fixed and placed on a monthly maintenance schedule and any time there is an issue that the employees are to report it.

However, you should be monitoring for condensation, splashing, and dripping frequently during processing to ensure adulteration of food does not occur rather than rely on employees notifying the supervisor. You stated (b)(4). Your response on July 18, 2025 also included a procedure prepared by your HACCP coordinator for preparing and use of Member’s Mark sanitizer a “(b)(4)” quat based sanitizer that is not appropriate. It does not list the expected concentration of use and testing of the sanitizer concentration as verification. It indicates that individuals will rinse areas (i.e., cutting board, knives, gloves, aprons, etc.) and then spray a solution of 1oz sanitizer to 1 gallon water on to the area every four hours, wait two minutes, and quick rinse with water. However, the instructions for use of this sanitizer are to be used on food contact surfaces after removal of gross food particles and cleaning with a good detergent followed by a potable water before application of the sanitizer in a manner that the surfaces remain visibly wet for at least 1 minute and allowed to air dry before contact with food. Sanitizer efficacy is detrimentally reduced by organic matter such as fish protein, which makes cleaning before sanitizing crucial. Additionally, when used on food contact surfaces, quat based sanitizers at the recommended concentration of up to 200 ppm do not need to be rinsed. You also provided blank templates of your ‘(b)(4)” records for the processing and fillet rooms in your July 18, 2025 response that do not provide a specific place to write the actual concentration of sanitizer used, and the records did not include observations to demonstrate implementation.

Las Vegas, NV
We reviewed your response received on October 9, 2025, to the above listed sanitation deficiencies found during the Las Vegas facility inspection and find the response to be inadequate. Your response stated (b)(4).” However, you provided completed “(b)(4)” records for September 29, 2025, through October 4, 2025, that do not record the actual concentration of sanitizer used.

Dallas, TX
We reviewed your response received on October 27, 2025, to the above listed sanitation deficiencies found during the Dallas facility inspection and find the response to be inadequate. Your response stated “(b)(4).” As a result, you created several new forms, including a new daily sanitation verification form, and conducted employee training. You additionally provided supporting documentation through four emails on November 14, 2025. You provided completed “(b)(4)” records for weeks that do not include the date of the observations and do not record the actual concentration of sanitizer used. We will discuss our continued concerns in the proposed regulatory meeting.

2. You must maintain adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11 (c). However, your firm did not maintain adequate sanitation monitoring records for conditions and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging materials, and food contact surfaces from adulteration; and proper labeling, storage and use of toxic compounds; required for the processing of raw RTE salmon and tuna at both your Los Angeles, CA and Oceanside, CA facilities. The records are inadequate because processing and other information was not entered on records at the time that it was observed in accordance with 21 CFR 123.9(a)(4). Specifically:

a. During production at your Los Angeles facility on June 25-26, 2025, and sanitation on June 25, 2025, an FDA investigator observed that your sanitation monitoring records were not filled out during the time they were observed. The investigator did not observe your employees enter information in the “(b)(4)” at (b)(4)AM on June 25, at (b)(4)AM on June 25, 2025, and at (b)(4)AM on June 26 as printed on the record. The investigator also did not observe your employee enter information in the “(b)(4)” during sanitation of the Fillet Room on June 25, 2025, at (b)(4)AM. These documents have a pre-filled out time for end of operations at (b)(4)PM.

b. At your Oceanside facility, an FDA investigator reviewed your “(b)(4)” dated April 17, 2025, which was blank, but signed and dated on April 17, 2025, by both the sanitation manager and by the HACCP Administration Associate.

We received your response to the Oceanside, CA inspection on June 10, 2025 and to your Los Angeles, CA inspection on August 11 and 18, 2025. Your response to the Oceanside findings included the (b)(4) form dated April 17, 2025 that had been check marked for the missing information on May 21, 2025. Your response is inadequate because you entered information onto records more than a month after the record was created and such retroactive recording is not a proper corrective action.

Your response for the Los Angeles findings includes revisions to the forms so that individuals must write in their name and the time the monitoring was completed, and that the new HACCP coordinator will work closely with QC personnel. These responses are inadequate. You should provide at least five recent days of these records to demonstrate that they are consistently being filled in with the individuals initials and dates. Additionally, we will verify the effectiveness of your corrective actions during our next inspection by verifying that the information is entered on the record at the time of the observation.

We remain deeply concerned that you have not provided evidence that you have successfully corrected the egregious insanitary conditions and practices in a manner that will prevent recurrence at each of these facilities. You should provide revised sanitation control procedures along with at least five days of monitoring records to demonstrate implementation and compliance with 21 CFR 123.11. Your sanitation controls procedures should provide the details that address the insanitary conditions and practices found at each facility and the frequency for monitoring should be increased to ensure compliance. For assistance with creating your sanitation control procedures and monitoring see the Sanitation Control Procedures for Processing Fish and Fishery Products document. The corresponding Sanitation Control Procedures course is offered though the Association of Food and Drug Officials (AFDO) training programs website.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that 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 firm 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.

In addition, we have the following comments:

Your response to this Warning Letter should at a minimum include records specific for each facility that includes a record with details for deep cleaning and sanitizing of equipment and facility intended to eliminate the resident strain of L. monocytogenes, revised environmental monitoring program for routine testing, results from environmental testing for Listeria spp., training material for employees, and employee training records. A written environmental monitoring program should include scientifically robust routine sampling to verify the successful exclusion of pathogens from areas where cross-contamination and adulteration are likely to occur and identify contamination when present. The plan should include processing area floor diagrams identifying equipment and collection sites, the type of sampling done, number of samples collected, frequency of collection, identification of sampling equipment, instructions for the collection of samples, timing of sample collection (e.g. several hours into production or prior to cleanup), specific analytical methods, the laboratory performing analysis, and corrective actions for Listeria spp. detected on food contact surfaces. Furthermore, we reviewed your environmental monitoring plan for Listeria signed and dated May 30, 2025, and recommend you consider adding the elements noted above. Your environmental monitoring plan also states you (b)(4). We recommend that you determine the appropriate number of food contact surface (FCS), and non-FCS sampling sites based on the size of your plant, plant features, product flow, characteristics of the RTE food, the processing methods used to produce the food, and previous sampling results. Additionally, because you process raw, RTE fish and you have the same pathogenic strain of L. monocytogenes present at multiple facilities, you should consider controls for the receiving of raw fish and additional controls within the facility. Recommendations for such controls can be found in FDA’s draft guidance to industry titled Control of Listeria monocytogenes in Ready-To-Eat Foods.

We recommend that you consider incorporating WGS as a tool to investigate pathogen isolates obtained in your environmental monitoring program. The use of WGS to analyze and investigate any pathogen isolated from your production environment or RTE food products would provide the most complete information available to identify and implement appropriate and effective corrective actions, including steps to prevent the contamination from recurring and steps to ensure contaminated product does not enter commerce.

Please notify FDA in writing within fifteen (15) working days of the receipt of this letter of the specific steps and corrections you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete correction actions 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.

We have scheduled a ninety (90) minute regulatory meeting to be conducted in person at the Food and Drug Administration, Los Angeles District Office, 19701 Fairchild, Irvine, CA 92612 on April 1, 2026 at 10:00AM PT to discuss these violations and your corrective actions. Please contact us within five (5) business days from receipt of this letter to confirm your attendance or request an alternate date.

To facilitate productive discussions, we encourage you to provide any supporting documentation of corrective actions in advance of the meeting. This may include revised HACCP plans, monitoring records, corrective action documentation, and verification records. Advance submission will allow agency personnel to review materials prior to the meeting and enable more focused discussions.

Please send your reply to confirm the above meeting details to the Food and Drug Administration, Attention: Elodie Tong-Lin, Compliance Officer, via email at Elodie.Tong-Lin@fda.hhs.gov. If you have any questions regarding this letter, you may contact Elodie Tong-Lin, Compliance Officer, via email at Elodie.Tong-Lin@fda.hhs.gov. Please reference CMS #715467 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

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