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  5. Ocean Group Inc. - 675713 - 04/17/2024
  1. Warning Letters

WARNING LETTER

Ocean Group Inc. MARCS-CMS 675713 —


Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Jason Y. Kim
Recipient Title
CEO
Ocean Group Inc.

1100 S Sante Fe Ave
Los Angeles, CA 90021
United States

Issuing Office:
Division of Human and Animal Food Operations West V

United States


WARNING LETTER

April 17, 2024

WL 675713 

Dear Mr. Kim:

The Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 1100 S Sante Fe Ave, Los Angeles, CA 90021 from December 11 -December 21, 2023. The inspection revealed 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). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations.

Based on FDA’s inspectional findings and the analytical results for samples collected from your production environment, we have determined that the ready-to-eat (RTE) salmon and tuna processed in your facility 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 were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the June 2022 Edition of the Fish and Fishery Products Hazards and Controls Guidance through links on the FDA’s homepage at www.fda.gov and https://www.fda.gov/media/80637/download.

We received your responses to FDA’s environmental sample findings via email on December 28, 2023, to the FDA-483 via email on January 4, 2024 and a follow-up email on January 13, 2024. Further, you recalled your RTE salmon and RTE tuna processed in your facility between December 11 through December 28, 2023 and voluntarily ceased processing of RTE seafood until you conducted your own environmental monitoring. We have addressed the details of your response in the letter below.

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 is able to 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. FDA investigators collected environmental samples from your processing facility on December 11, 2023 and December 12, 2023. FDA analysis of the environmental samples (1195789 and 1239088) confirmed that thirty-four (34) of one hundred (100) environmental swabs were positive for pathogenic L. monocytogenes. For example:

  • Two (2) swabs were collected from direct food contact surfaces in your (b)(4) room including the food contact surfaces of (b)(4) used to process ready-to-eat salmon and (b)(4) used to process ready-to-eat salmon.
  • Multiple swabs collected from processing areas in your (b)(4) room:

    o (b)(4) of the (b)(4), (b)(6), (b)(7)(C) table that employees were observed handling.
    o (b)(4), (b)(6), (b)(7)(C) table.
    o Employee’s yellow-orange plastic apron hung on the left swinging door of the “(b)(4) room,” (b)(4), (b)(6), (b)(7)(C) table.
    o Underside of (b)(4), (b)(6), (b)(7)(C) table.
    o (b)(4) the red shutoff valve handle, (b)(4) to (b)(4), (b)(6), (b)(7)(C) table.
    o Stainless steel wall (b)(4), (b)(6), (b)(7)(C) table.
    o (b)(4) where employees store RTE packaged tuna.
    o Floor section (b)(4) where investigators observed standing water, and high employee and equipment traffic.

  • Multiple swabs collected (b)(4):

    o (b)(4) that was stacked on top of other bins. There were no distinguishing features for which bins are placed on the floor and which bins are used for holding products.
    o Rim of the floor drench in front of the fillet room where investigators observed high foot and equipment traffic during operations.
    o (b)(4) of (b)(4) that employees use to move pallets of unprocessed and processed fish and equipment throughout the plant.
    o Plastic brush on the wood push broom used to push standing liquid on the floor to floor drains throughout the production area.

Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates. The analysis of the WGS data of the referenced samples showed three (3) strains of L. monocytogenes are present in your facility. Most notably, one of these strains was identified in twenty-eight (28) isolates and matched four (4) clinical isolates (2017, 2018, 2019, and 2023), indicating that this strain is known to cause human illness, however, no epidemiological data was available to link the clinical isolate to your facility. Two other strains were identified in one (1) and four (4) isolates, respectively, which matched various product isolates collected from other firm(s) located in Wisconsin, Tennessee, the Netherlands, and the United Kingdom, but no clinical isolates. We advised you of these WGS results via a conference call on January 5, 2024.

The presence of L. monocytogenes in your facility and your products is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food. Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen. Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it 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 take such corrective actions as are necessary to eradicate the organism.

We note that FDA environmental samples (1195789 and 1239088) also isolated thirty (30) swabs with non-pathogenic Listeria species including L. innocua, L. seeligeri, and L. welshimeri. Some of these positive swabs were found on direct food contact surfaces, and other areas where you process RTE seafood products in your fillet room. The presence of non-pathogenic Listeria species is indicative of conditions that are suitable for the survival and/or growth of the pathogen L. monocytogenes.

Your response to the findings included voluntary product recall; voluntarily cessation of production; cleaning and sanitizing and environmental sampling; updated sanitation procedures; and cessation of the use of (b)(4). However, your response cannot be fully evaluated due to of a lack of supporting documentation, such as environmental swab results for the staging room/warehouse areas that were found positive and sanitation monitoring records.

Seafood HACCP Violations (21 CFR Part 123):

You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with current good manufacturing practice requirements in 21 CFR Part 117, Subpart B (CGMPs), that are both appropriate to your plant and the food being processed and relate to one of the areas specified in 21 CFR § 123.11(b)(1)-(8), to comply with 21 CFR § 123.11(b). However, you failed to monitor persons working in direct contact with food, food-contact surfaces and food-packaging materials with sufficient frequency to ensure that such persons took necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.10(b)(9). This is related to the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product, 21 CFR § 123.11(b)(3). Specifically, the following observations occurred on 12/11-13/2023 in the fillet room, where you process RTE tuna and RTE salmon:

  • Employees were observed using (b)(4) to spray gray plastic bins, Styrofoam boxes, cutting boards, walls, and table drains, in a manner that resulted in backsplash from these items and the floor into the air and onto surrounding areas, including the production room tables with cutting boards, onto exposed RTE salmon, the ice table, aprons of employees, and other surfaces in the vicinity. Additionally, the floor was observed to be pitted with cracks, with standing pools of water.
  • Employees were observed handling a scaler rod to turn on/off the scaler, then handling RTE salmon without washing or sanitizing their hands.
  • Investigators observed a black residue on the wall joints that came into frequent contact with the blue plastic liner used to wrap processed salmon fillets for sushi.

We evaluated your responses received on December 28, 2023, January 4, 2024 and January 13, 2024, in which you informed us that you destroyed and discarded all fresh salmon products that entered your facility prior to December 23, 2023, ceased production of RTE salmon and RTE tuna until your environmental sampling resulted in negative findings, conducted a deep cleaning and sanitizing, ceased the use of (b)(4), and stated that you would train employees, install new scalers, replace the blue plastic liner, designate the gray bins, fill the pits and cracks in the floor and create new sanitation procedures. However, we are unable to fully evaluate your response as you did not provide all supporting documents, such as sanitation monitoring records and other evidence that demonstrates that planned actions have been completed (e.g., training documents, photographs of corrections).

This letter is not intended to be an all-inclusive statement of violations that may exist 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 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 without further notice, 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 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 corrective actions within fifteen (15) working days, state the reason for the delay and the time 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.

Your written response should be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild
Irvine, CA 92612

Refer to Unique Identification Number 675713 when replying.

If you would prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification Number in the title of the e-mail message.

If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov or 510-337-6870.

Sincerely,
/S/

Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5

 
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