WARNING LETTER
Harbor Marine Product Inc.
MARCS-CMS 710589 —
November 28, 2025
Delivery Method:
VIA ELECTRONIC DELIVERY
Product:
Food & Beverages
Recipient:
Recipient Name
Joon Do Kim
Recipient Title
Owner
Harbor Marine Product Inc.
5088 Fruitland Ave
Vernon
,
CA
90058-2715
United States
harbormarineproduct@gmail.com
Issuing Office:
Office of Compliance and Enforcement
United States
November 28, 2025
WARNING LETTER
Re: CMS #710589
Dear Mr. Kim:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility and importer establishment, located at 5088 Fruitland Ave, Vernon, CA 90058-2715, from March 5, 2025, through March 27, 2025. During our inspection, FDA found evidence of 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). In addition, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility.  FDA laboratory analyses of the environmental swabs found the presence of non-pathogenic
Listeria
spp. in
(b)(4)
% of the swabs collected at your facility.
Based on FDA’s inspectional findings and analytical results for samples collected from your processing environment, we have determined that your raw, ready-to-eat (RTE) fish 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)).
In addition, as an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), and may be denied entry into the United States.
You may find the Act and further information about FDA’s regulations through links in FDA’s home page at http://www.fda.gov.
At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. You provided responses to the FDA-483 on April 18, 2025, and May 2, 2025, which included a description of corrective actions taken by your firm. After reviewing the inspectional findings and your firm’s response, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response below.
Environmental Testing of Your Facility
Our inspection included the collection of environmental swabs (FDA Sample #1253177) from various areas in your processing facility on March 10, 2025, during the production of raw, RTE salmon (raw, RTE tuna was previously processed on the same day). FDA laboratory analysis found that
(b)(4)
of the
(b)(4)
environmental swabs were positive for non-pathogenic
Listeria
spp., including
Listeria innocua
,
Listeria welshimeri
, and
Listeria grayi
. Of the
(b)(4)
positive swabs,
(b)(4)
% (
(b)(4)
swabs) were collected from food contact surfaces in areas where raw, RTE salmon and tuna are processed. The positive food contact surfaces included:
• cutting board surface on fillet tables where raw, RTE salmon was touching;
• surfaces of tools, including pliers and knives, used to directly cut and manipulate raw, RTE salmon;
• table dividers, edges, and corners where raw, RTE tuna and salmon contacts;
• blade and handle of knife in ice bed used to cut raw, RTE tuna;
• water drain hole at the end of table where raw, RTE salmon is handled;
• cutting board surface of corner fillet table (where condensate was observed dripping from the air conditioning unit) where raw, RTE tuna and salmon contacts.
The high level of non-pathogenic
Listeria
spp. in your facility demonstrates your sanitation procedures have been inadequate to effectively control microbiological contamination in your facility. Appropriate control of
Listeria
spp. in a food processing environment requires knowledge of the unique characteristics of the organism and implementation of the hygienic practices necessary to control this microbe. Once
Listeria
spp. is established in a production area, personnel or equipment can facilitate the microbe’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.
The presence of non-pathogenic
Listeria
spp. indicates insanitary conditions suitable for the survival and growth of the pathogenic
Listeria monocytogenes (L. monocytogenes
). If
L. monocytogenes
is introduced into a food processing facility without proper controls, it can proliferate in the food processing environment where it may contaminate food. Consuming food contaminated with
L. monocytogenes
can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness which is a major public health concern due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.
We acknowledge your responses dated April 18, 2025, and May 2, 2025, and find them to be inadequate. Your corrective actions do not fully address the
Listeria
spp. findings in your facility, and your responses did not include corrective actions such as a procedure for environmental monitoring, any indication you are performing environmental swabbing (including to verify intensified cleaning and sanitation), and a root cause analysis. The root cause analysis should evaluate potential sources and explain the basis for their elimination. If the likely source of contamination cannot be identified, then the root cause analysis should thoroughly investigate and evaluate all potential sources, implemented controls, and problems. As a processor of raw, ready-to-eat (RTE) fish, you are responsible for ensuring that you have Listeria controls in your facility to prevent
L. monocytogenes
from contaminating your products.
Seafood HACCP (21 CFR Part 123)
Additionally, numerous serious insanitary conditions and practices were observed in your facility during your most recent FDA inspection. The following are concerning because they are potential pathways for the contamination of your raw, RTE products:
1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure conformance with the conditions and practices specified in 21 CFR Part 117 Subpart B (current good manufacturing practice (CGMP) requirements) that are both appropriate to the plant and the food being processed and relate to the items listed in 21 CFR 123.11(b).  However, your firm did not monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with CGMP requirements, as evidenced by the following serious observations during the FDA inspection.
a. You did not conduct all food manufacturing, processing, packing, and holding under conditions and controls necessary to minimize the potential growth of microorganisms, contamination of food, and deterioration of food, as required by 21 CFR 117.80(c)(2). 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, as required by 21 CFR 123.11(b)(3).
i. On March 6 and March 10, 2025, an employee was observed dropping the hose head onto the floor, the hose was observed falling from the anchor point onto the floor, and employees were observed picking the hose and hose head off the floor with fabric gloved hand and returning to handle raw, RTE salmon without sanitizing the hose head or gloved hand. The hose was used constantly during production to spray down the salmon and food contact surfaces. Hose heads were also observed to be hanging     from blue bins used for fish waste that are emptied into larger bins for lobster feed and are returned to processing areas without cleaning and sanitizing. FDA environmental swab subsample #
(b)(4)
was collected from a hose handle by a packing table. Employees touch and hang the hose handle on blue waste bins before directly handling raw, RTE salmon. Subsample #
(b)(4)
was found positive for
L. innocua
. FDA environmental swab subsample #
(b)(4)
, collected from cracked top edge of blue waste bin, was found positive for
L. innocua
.
ii. On March 6 and March 10, 2025, the drain by descaler operations had pooling water in at least a five-foot radius, into the surrounding area, and the water was over an inch high. Drains can be contaminated with pathogens and pooling water around drains can be a source of splash that can spread the contamination around processing areas and potentially contaminate food and food contact surfaces.  Carts of boxed product were observed being pushed through the water, a wooden pallet was soaked in the water, and cases of salmon were stored directly on the floor. FDA environmental swab subsample #
(b)(4)
, collected from a wheel of a cart containing boxes of product, was found positive for
L. innocua
. Additionally, employees were observed using fabric-gloved hands to intermittently grab and pull a line attached to the drain grate submerged in the pooling water, in order to release water; the employees returned to handling raw, RTE salmon without changing, washing, or sanitizing their hands/gloves.     This line attached to the drain gate was the site for FDA environmental swab subsample #
(b)(4)
, which was found to be positive for
L. innocua
. Furthermore, your pre-op and post-op sanitation monitoring record on both days when these observations were made noted the “hands, gloves, equipment and utensils washed/sanitized after contact with unsanitary objects” as acceptable, when it was not acceptable.
iii. On March 6, 2025, Styrofoam cases used to hold fish, including exposed raw, RTE salmon, were stored on the floor in the
(b)(4)
area in contact with run-off water from
(b)(4)
and in contact with a drain.
(b)(4)
fish and
(b)(4)
fish are placed back into the Styrofoam cases before
(b)(4)
, and the cases are stacked after they have been on the floor. Furthermore, the extra cases and lids are stored overnight outside behind the trash bin for use in the morning as shipping containers. Styrofoam is a material that consists of fused foam beads which can provide channels for water and harborages for pathogens.
iv. On March 6, 2025, a
(b)(4)
tool, used to
(b)(4)
raw, RTE salmon, was hanging and touching a wet wooden pallet on the floor. The
(b)(4)
was not sanitized prior to use. Your HACCP Coordinator stated
(b)(4)
.
v. On March 6, 2025, overspray and mist from an employee hosing down a wooden pallet was observed while an immediately adjacent table was used for cutting and
(b)(4)
raw, RTE salmon. Overspray and mist from insanitary objects (e.g., wooden pallet) can transport and spread bacterial pathogens to contaminate adjacent food and food contact surfaces.
b. You did not prevent drip or condensate from fixtures, ducts and pipes from contaminating food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.20(b)(4). This is related to the protection of food, food packaging material, and food contact surfaces from adulteration with condensate, as required by 21 CFR 123.11(b)(5).
On March 6 and March 10, 2025, condensate was dripping onto a filleting table during the processing of raw, RTE salmon and during sanitation, respectively.  Additionally, your pre-op and post-op sanitation monitoring records on both days these observations were made noted the “
(b)(4)
” as acceptable when it was not acceptable.  FDA environmental swab subsample #
(b)(4)
collected from the food contact surface of the filleting table was positive for
L. grayi
.
2. You must conduct or have conducted for you a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you produce and have and implement a HACCP plan that lists the critical control points for each food safety hazard you identified in your hazard analysis, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your HACCP plans for scombroid and non-scombroid fish that are consumed as raw, RTE do not list critical control points to control cumulative time and temperature exposures for the unrefrigerated processing during
(b)(4)
to control pathogen growth and toxin formation and (for scombroid fish) histamine formation. These unrefrigerated processing steps were observed to occur at ambient air temperatures up to 57°F.
3. You must implement your written HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not implement the procedures at the following critical control points (CCP’s) listed in your HACCP plans for scombroid and non-scombroid fish that are consumed as raw, RTE. This is a repeat observation from the FDA inspection dated February 11 to February 12, 2020.
a. Your firm did not follow the monitoring procedure of continuously monitoring the cooler temperature with a data logger to ensure that the cooler temperature does not exceed
(b)(4)
°F at the
(b)(4)
CCP, as stated in your HACCP plans for scombroid and non-scombroid fish that are consumed as raw, RTE. In practice you only document the temperature twice per day around
(b)(4)
AM and
(b)(4)
PM by reading the non-continuous, digital thermometers. You do not have any continuous temperature recording devices for measuring cooler temperature.
b. Your HACCP plan for non-scombroid fish that are consumed as raw, RTE identifies freezing as a control for parasites. In practice, you do not freeze any of your fresh fish.
c. Your HACCP plans for scombroid and non-scombroid fish that are consumed as raw, RTE identify undeclared major food allergens as a hazard at the Finished Product Labeling CCP.  Your critical limit states finished products labels must declare the presence of fish and shellfish, with a visual examination of labels in every container to be documented on a record of review of finished product labels. However, you did not have any CCP monitoring records and your finished product had no labels other than a logo/brand sticker.
d. You are not following your verification procedure of “
(b)(4)
” as stated at the
(b)(4)
CCP and
(b)(4)
CCP in your HACCP plans for scombroid and non-scombroid fish that are consumed as raw, RTE. In practice, you calibrate all thermometers in-house
(b)(4)
by comparing the temperatures to a handheld thermometer. In addition, you perform weekly accuracy checks with a requirement of
(b)(4)
F degrees, but you do not indicate a baseline temperature for which the range begins, and you only perform regular accuracy checks on
(b)(4)
out of the approximately
(b)(4)
thermometers your firm uses.
4. You must have and implement written verification procedures for ensuring that the fish and fishery product(s) you offer for import were processed in accordance with the seafood HACCP Regulation, to comply with 21 CFR 123.12(a)(2). You import fish such as salmon, halibut, shad, and flounder from Canada, the United Kingdom, the Republic of Korea, and the Faroe Islands; however, you have no importer verification procedures, including no product specifications, and no affirmative step or records showing that the seafood products offered for import were processed in accordance with the seafood HACCP Regulation. This is a repeat observation made during previous FDA inspections in 2017 and 2020.
We reviewed your responses dated April 18, 2025, and May 2, 2025, and we are unable to assess their adequacy. Your responses described actions that you have taken, including repairs to the cooler unit, drain maintenance, employee training, revising standard sanitation operating procedures (SSOPs), revised SSOP monitoring, purchasing new continuous temperature recording devices, revising your HACCP plans, creating new procedures, obtaining importer verification documentation for foreign suppliers, and training employees. However, your corrective actions did not include adequate supporting documentation as evidence of implementation of your actions such as revised SSOPs, copies of SSOPs monitoring records for five consecutive processing days following implementation of corrective actions, employee training records, records for cooler unit repairs and drain maintenance, revised HACCP plans, description and process flow diagram that include your new processing steps, and copies of your CCP monitoring records for five processing days to demonstrate implementation. We encourage you to submit supporting documentation.
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 by the FDA 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 the receipt of this letter as to 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 documents.  If you cannot complete all corrections within fifteen (15) 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 reply via email to the U.S. Food and Drug Administration, Attention:  Michael Dominick, Compliance Officer at Michael.Dominick@fda.hhs.gov. If you have any questions regarding this letter, please contact Mr. Dominick at (301) 837-4300 or to the email address listed above. Please include reference #710589 on all submission documents and in the subject line of any email correspondence to the agency.
Sincerely,
/s/
Maria Knirk, J.D., MBA
Acting Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
12/16/2025
Regulated Product(s)
Food & Beverages