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  5. Min Jiang Food Store Inc dba Koi Koi Trading - 718312 - 01/14/2026
  1. Warning Letters

WARNING LETTER

Min Jiang Food Store Inc dba Koi Koi Trading MARCS-CMS 718312 —

Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Renfen Qiu
Recipient Title
President/Owner
Min Jiang Food Store Inc dba Koi Koi Trading

2710 Yates Avenue
Commerce, CA 90040-2624
United States

bobby@koikoitrading.com
Issuing Office:
Human Foods Program

United States

January 14, 2026

WARNING LETTER

Re: CMS Case # 718312

Dear Mr. Qiu:

The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) seafood processing facility, located at 2710 Yates Avenue, Commerce, CA 90040-2624, from June 10 through June 24, 2025. During our inspection, FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, 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 non-pathogenic Listeria welshimeri (L. welshimeri).

Based on FDA’s inspectional and the analytical results for samples collected from your production environment, we have determined that your raw, RTE fish products, including salmon, 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 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 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 Act [21 U.S.C. § 342(a)(4)]. Accordingly, your fresh tuna portions are also 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 Edition of the Fish and Fisheries Products Hazards and 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 a Form FDA 483 (FDA-483), Inspectional Observations, listing the violations found at your facility. You provided a response to the inspection on July 3, 2025, describing corrective actions taken or planned by your firm. After reviewing the inspectional findings, analytical results, and the response that your firm provided, 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.

Environmental Samples

FDA investigators collected environmental swabs (FDA Sample 1267630) from various areas in your processing facility on June 17, 2025, during the production of RTE fresh aquacultured imported salmon intended for raw consumption. FDA laboratory analysis found that forty-one (41) of the one hundred ten (110) environmental swabs were positive for non-pathogenic L. welshimeri. Of the 41 positive swabs, (b)(4)% (fourteen (14) swabs) were collected from food-contact surfaces in areas where raw, RTE salmon products are processed. The positive food-contact surfaces included:

  • the blades of the small and large Victorinox knives on the shelf of table (b)(4) that are used to cut RTE fish;
  • the blade of the Victorinox knife on the shelf of table (b)(4) that is used to cut RTE fish;
  • the (b)(4) surface of table (b)(4) where RTE fish is prepared;
  • the (b)(4) surfaces of table (b)(4) where RTE fish is prepared; and
  • the (b)(4) surface of table (b)(4) where RTE fish is prepared.

Furthermore, your firm has a history of Listeria contamination, including pathogenic Listeria monocytogenes (L. monocytogenes) in your facility. During a previous FDA inspection, environmental sample 1132407 collected on March 9, 2020, from various areas in your firm’s processing facility identified three (3) of ninety-eight (98) swabs positive for L. monocytogenes, including one (1) positive swab from a food-contact surface (i.e., the top of table (b)(4), which is the cutting board used for de-scaling and filleting RTE salmon). Whole genome sequencing (WGS) conducted on these L. monocytogenes isolates revealed that the isolates were genetically identical to one another, representing the same strain. Furthermore, this strain was highly related to another fifteen (15) environmental isolates collected in 2015 and 2016 from another food processing facility in California. Additionally, forty-eight (48) of ninety-eight (98) swabs were positive for Listeria species, including L. innocua and L. welshimeri. We advised you of the importance of these Listeria findings during a Regulatory Meeting held with your firm on May 5, 2020.

The high-level of non-pathogenic Listeria species in your facility demonstrates your sanitation procedures have been inadequate to effectively control microbial contamination in your facility. Appropriate control of Listeria species 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 species 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 species indicates insanitary conditions suitable for the survival and growth of the pathogenic L. monocytogenes, which, as noted above, has been previously found in your facility including on a food-contact surface. If L. monocytogenes is introduced into a food processing facility without proper controls, it can proliferate in food processing facilities 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 that your July 3, 2025, response included an updated “(b)(4),” revised June 23, 2025, and environmental sampling conducted on June 20 and 27, 2025, that showed negative results for L. monocytogenes for fourteen (14) swabs. However, FDA is unable to evaluate if you are adequately controlling Listeria and if you are monitoring the sanitary conditions and practices in your facility for the reasons discussed below.

Your updated “(b)(4)” includes (b)(4). However, your program lists analysis methodology for L. monocytogenes and the environmental sampling results you provided used method AOAC 2004.02 to determine that no L. monocytogenes was present. FDA recommends you provide evidence that your environmental monitoring tested for other species of Listeria such as L. welshimeri. Additionally, FDA recommends you provide records with details of the cleaning and sanitizing of the environmental surfaces where FDA detected Listeria species, and provide the corrective actions taken to prevent the recurrence of Listeria species in your facility such as a comprehensive investigation or root cause analysis to identify the source of the Listeria contamination. As a processor of raw, RTE fish, you are responsible for ensuring that you have Listeria controls in your facility to prevent L. monocytogenes from contaminating your products. 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.

Moreover, your environmental monitoring program is not clear on when corrective actions will be taken when testing for Listeria species. For example, (b)(4). FDA recommends your environmental monitoring program clearly state the methods of analysis for all Listeria species and a list of corrective actions your firm will take should any Listeria species be detected on a surface (i.e., positive).

Furthermore, your program states that (b)(4). This is not statistically robust sampling to determine control of L. monocytogenes, particularly given FDA’s history of finding Listeria, including L. monocytogenes, in your processing environment, including on zone (b)(4) food-contact surfaces.

Seafood HACCP Violations (21 CFR Part 123)

Your significant violations are as follows:

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. This is a repeat violation from FDA’s 2020 inspection.

A. You did not ensure all food-contact surfaces, including utensils, were cleaned as necessary to protect against food contamination, as required by 21 CFR 117.35(d). This is related to the condition and cleanliness of food-contact surfaces, including utensils and gloves, as required by 21 CFR 123.11(b)(2). Specifically, the FDA investigator observed:

i. On June 10, 2025, organic fish-like material on tools, such as knives and knife sharpening steels, after the tools were sanitized. The knives were food-contact surfaces used to fillet RTE fresh salmon. Additionally, rust-like material was observed on the knife sharpening steels that contact the blades of the knives. L. welshimeri was found on the blades of the small and large Victorinox knives on the shelf of table (b)(4); blades of the black and purple sharpener on the shelf of table (b)(4); and the blade of the Victorinox knife on the shelf of table (b)(4) (Sample 1267630, subs 28, 30, 62, and 65).

ii. On June 11, 2025, an employee handling and processing RTE fresh salmon dropped their knife on the fresh fish processing room floor. The employee picked up the knife from the floor and rinsed the knife with water from the metal nozzle attached to a black water hose hanging from the rim of a gray waste barrel. The employee then continued handling and processing RTE fresh salmon without cleaning and sanitizing the knife or washing their hands and changing gloves.

B. 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 and gloves, as required by 21 CFR 123.11(b)(3)). Specifically, the FDA investigator observed:

i. On June 11, 2025, an employee placed a fresh salmon head in a gray waste barrel while handling and processing RTE fresh salmon. The employee then reached their gloved hand into the gray waste barrel, picked up the fresh salmon head, and placed it on cutting board (b)(4) where RTE fish is prepared. Thereafter, the employee placed the fresh salmon head into a transparent plastic poly bag to be sold and distributed by your firm. L. welshimeri was found on the handles, rim, interior, and wheel of a gray waste barrel in front of table (b)(4), on the (b)(4) surface of table (b)(4) (i.e., cutting board (b)(4)) where RTE fish is prepared, and the rim of a gray waste barrel in front of table (b)(4) (Sample 1267630, subs 44, 45, 46, 47, 48, 49, 50, 96). Additionally, during FDA’s 2020 inspection, L. monocytogenes was found on the surface of table 2 and the top rim of a gray waste barrel (Sample 1132407, subs 9, 57, and 58).

ii. On June 10 and 11, 2025, blue plastic swinging doors heavily soiled with unidentified foreign material at push points located at the entrance/exit to the fresh fish processing room. Employees touched these blue plastic swinging doors with their gloved hands when transferring RTE fresh salmon from the walk-in cooler to the fresh fish processing room. The same employees continued to handle RTE fresh salmon without washing their hands and changing their gloves. Furthermore, on June 17, 2025, these same blue plastic swinging doors were still heavily soiled with unidentified foreign material at push points located at the entrance/exit to the fresh fish processing room. L. welshimeri was found on the (b)(4) side of the (b)(4) door and (b)(4) side of the (b)(4) door leading into the production room, and (b)(4) side of the (b)(4) door and (b)(4) side of the (b)(4) door leading out of the production room (Sample 1267630, subs 9, 10, 88, and 89).

iii. On June 10 and 11, 2025, hanging metal water hose nozzles with build-up of apparent organic fish-like material on the top rims of gray waste barrels while employees were handling and processing RTE fresh salmon in the fresh fish processing room. The waste barrels were not a clean and sanitary surface. These same metal water hose nozzles were used to rinse cutting boards and RTE fresh salmon. Furthermore, these employees continued to handle and process RTE fresh salmon without washing their hands and changing their gloves. L. welshimeri was found on the nozzle and handle of the hose on the shelf of tables (b)(4) (Sample 1267630, subs 69 and 73). Additionally, during FDA’s 2020 inspection, L. monocytogenes was found on the top rim of a gray waste barrel (Sample 1132407, 57 and 58).

iv. On June 10 and 11, 2025, employees handling and processing RTE fresh salmon in the fresh fish processing room were rinsing out the interior surface of Styrofoam containers used for packing RTE fresh salmon. The employees were rinsing one Styrofoam container on its side on a wood pallet, one Styrofoam container on its side and contacting an employee’s boot, and one Styrofoam container on its side and contacting the fresh fish processing room floor. Employees placed RTE fresh salmon into these same Styrofoam containers without any protective packaging.

v. On June 10 and 11, 2025, an employee handling and de-scaling RTE fresh salmon in the fresh fish processing room and then moving wood pallets outside of the fresh fish processing room. When re-entering the fresh fish processing room, the employee continued to de-scale RTE fresh salmon without washing their hands and changing their gloves.

C. You did not ensure cleaning and sanitizing of utensils and equipment was conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). This is related to protection of food, food packaging material, and food-contact surfaces from adulteration, as required by 21 CFR 123.11(b)(5). On June 10, 2025, while monitoring post processing cleaning and sanitation, the FDA investigator observed back-splash and over-spray of water from high pressure water hoses contacting the floor, causing water droplets to land on the plastic poly bags used to pack RTE fresh salmon. Additionally, these same plastic poly bags were being stored in the fresh fish processing room in yellow plastic crates with evidence of unidentified foreign material build-up on the exterior and interior surfaces of the crates.

Your July 3, 2025, response explained that “(b)(4).” Additionally, you explained that you installed new plastic curtains in the cooler, and that you have ordered new plastic curtains for the large freezer and cooler entrances and will replace them immediately upon receipt. You also provided an employee training record for training conducted on June 28, 2025, and a photograph of replacement curtains for the cooler. However, your response is inadequate, as you did not discuss any other corrective actions you have taken, such as cleaning and sanitizing of surfaces observed to be insanitary and potentially contaminated. Additionally, you did not provide any sanitation monitoring records required by 21 CFR 123.11(b) demonstrating that you are documenting the monitoring and corrections for conditions and practices during processing.

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). However, your firm does not have a HACCP plan for fresh tuna portions to control the food safety hazard of scombrotoxin (histamine) formation when receiving tuna on ice and during refrigerated storage in your facility. Specifically, you stated that (b)(4); however, you do not evaluate adequacy of ice or conduct temperature monitoring checks upon receipt of the tuna. Additionally, you do not monitor refrigerated storage temperatures to control histamine formation.

Your July 3, 2025, response stated that (b)(4). To date, we have not received your HACCP plan for fresh tuna portions.

3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of “(b)(4)” for when products are received with frozen gel packs at the “(b)(4)” critical control point to control pathogen growth and toxin formation listed in your HACCP plan for “(b)(4),” revised October 1, 2024. During the inspection, your firm told the investigator that (b)(4). Therefore, you are not implementing the monitoring procedure listed in your HACCP plan to measure the internal temperature of the product.

Your July 3, 2025, response explains that (b)(4). However, you did not provide critical control point monitoring records for receiving to support your corrective action. You did not demonstrate that you are performing evaluations for adequacy of frozen gel packs or adequacy of ice, in addition to taking the internal product temperature or data loggers that show temperature was maintained below (b)(4)°F on shipments over (b)(4) hours as listed in your HACCP plan.

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.

Please notify FDA in writing within fifteen (15) working days of 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 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.

Please send your reply to the Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, via email at Sheena.Phillips@fda.hhs.gov.If you have any questions regarding this letter, you may contact Sheena Phillips, Compliance Officer, via email at Sheena.Phillips@fda.hhs.gov. Please reference CMS #718312 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, J.D., M.B.A.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Food and Drug Administration

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