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  5. Sugiyo USA Inc. - 607399 - 07/15/2020
  1. Warning Letters


Sugiyo USA Inc. MARCS-CMS 607399 —

Delivery Method:
Certified Mail
Food & Beverages

Recipient Name
Susan M. Ruiz
Recipient Title
Sugiyo USA Inc.

P. O. Box 468
Anacortes, WA 98221
United States

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

United States

July 15, 2020

In reply, refer to CMS 607399


Dear Ms. Ruiz:

The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 3200 T Avenue, Anacortes, Washington, on February 26 - 28, 2020, and March 2, 3, and 13, 2020. During our inspection, we collected environmental samples (swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).

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)]. Based on the results of our inspectional findings, including review of your HACCP plan and environmental testing, we have determined that your ready-to-eat (RTE) surimi-based seafood analog products are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may become contaminated with filth or rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

At the conclusion of the inspection, the FDA investigators issued you a Form FDA 483 (FDA 483), Inspectional Observations. You provided a response to the FDA 483 on April 3, 2020, which included corrective actions you have taken and continue to take.

We have reviewed the response and attachments and continue to have serious concerns as further described in this letter.

Presence of L. monocytogenes

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, L. monocytogenes 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 laboratory analysis of environmental samples collected from the pre-pasteurization area during the production of RTE surimi-based seafood analog products (sample INV 1128144 collected on February 26, 2020, and sample INV 1128145 collected on February 27, 2020) determined that nine (9) of one hundred and forty-three (143) environmental swabs tested positive for L. monocytogenes. Seven (7) of the positive swabs were collected from food-contact surfaces which included the conveyer belts; the red color spray nozzle; stainless steel roller; (b)(4) cutter machine; and the surimi paste cart prior to pasteurization. The two (2) other positive swabs were found on areas (a trench drain and the wheel of a cart) near food contact surfaces in your main processing room.

FDA conducted whole genome sequencing (WGS) analysis on the nine (9) L. monocytogenes isolates described above. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. The WGS phylogenetic analysis found that the nine isolates are within 41 single nucleotide polymorphisms (SNPs) apart, which is a bit larger than normally seen for isolates that are considered to originate from the same source, but it indicates the isolates are highly related to each other. When compared to the database, no other closely related isolates were identified.

Additionally, your environmental testing records show your firm identified Listeria species in thirteen (13) post-cook locations (food-contact surfaces and areas directly adjacent to food-contact surfaces) between December 12, 2019, and February 18, 2020. However, your firm did not take and/or document adequate corrective action in response to these findings.

FDA’s findings, along with your testing results, indicate that your firm is not implementing effective methods and controls to eliminate L. monocytogenes or minimize its presence on food and food-contact surfaces. Appropriate control of L. monocytogenes in a food processing environment requires expert knowledge of the unique characteristics of the organism and the corresponding hygienic practices necessary to eliminate this pathogen. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism. 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.

Your response described the following corrective actions taken in response to our findings of L. monocytogenes in your facility: hold all products produced on February 26 and 27, 2020; re-test finished product lots for L. monocytogenes; clean the production area; and re-test your production area. Your response also included testing results and a training record for microbiological testing. However, your response did not indicate that you conducted an investigation to identify the cause of the contamination (e.g., root cause analysis) and did not include a copy of your revised environmental monitoring procedure from section 2.4.8 of your SQF 2.4 Food Safety System.

We recommend your environmental monitoring procedure include the following actions:

  • Identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring;
  • Identify the timing and frequency for collecting and testing samples;
  • Identify the laboratory that will be conducting the testing and identify the analytical method(s) that will be used; and
  • Establish corrective action procedures you will implement when Listeria spp. or L. monocytogenes is found.

Your response included your environmental testing results for February 26, 2020, to March 6, 2020, which show four positive samples for L. monocytogenes. These positive samples were listed as “East Inlet Roller Eastside-(b)(4),” “East (b)(4) Belt Westside- (b)(4)” and two as “(b)(4).” However, your response did not provide sufficient context regarding where these samples were collected, and the corrective actions you took in response.

Note that FDA has issued a Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods. When finalized, the draft guidance will represent FDA’s current thinking on this topic.

Seafood HACCP

1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 117, Subpart B, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B:

a. Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces (21 CFR 123.11(b)(3)) as evidenced by:

  i. Water observed dripping from the exterior wall at the entrance of the individual quick frozen (IQF) freezer (b)(4) directly onto pasteurized, unwrapped, RTE Alaska Snow Leg surimi-based analog products and a conveyor belt which conveys these products. Your response stated that you will remove ice from the entrance of the IQF (b)(4) as the ice accumulates in the area and investigate a permanent solution. Your response did not include a timeframe for when you expect to have and implement a permanent solution to address this issue.

  ii. As a result of your sanitation activities using a high-pressure hose, aerosolized water was observed throughout the north end of the RTE processing area where pasteurized, unwrapped, RTE Alaska Snow Leg surimi-based analog products are processed. FDA investigators also observed production using equipment on which vaporized water contacted food-contact surfaces such as conveyor belts, weighing equipment, a (b)(4) table, and bagging equipment used to process pasteurized products. High-pressure hoses should not be used in processing areas due to the potential for cross-contamination through the aerosolization of pathogens. Your response did not address this issue.

  iii. The walls of the RTE processing area had peeling paint and an accumulation of apparent mold/mildew. Your response did not address this issue.

  iv. The underside of the conveyor belt after the (b)(4) table was heavily soiled. This belt conveys pasteurized, unwrapped, RTE frozen Alaska Snow Leg surimi-based analog products. Your response did not address this issue.

  v. The handle of a water hose nozzle was stored directly on a heavily soiled water pipe. Water from this nozzle was used for sanitation purposes and as an ingredient (b)(4) to produce surimi paste. Your response did not address this issue.

  vi. The underside of an insulated water line was heavily soiled near the Alaska Snow Leg Line green (b)(4) conveying belts. Your response did not address this issue.

b. Protection of food from adulteration with sanitizing agents (21 CFR 123.11(b)(5)), as evidenced by the following:

FDA investigators measured water drops and detected approximately (b)(4) dripping directly onto pasteurized, unwrapped, RTE Alaska Snow Leg surimi-based analog products as the product was conveyed and passed through the incline conveyor and passed through the (b)(4)  conveyor and (b)(4) bagging area. Your Quality Control Assistant Manager informed FDA investigators that (b)(4) water sprays are applied to the line where post-cook RTE products are conveyed to prevent pathogen introduction after pasteurization. Sanitizing solutions when used on food contact surfaces are not to exceed (b)(4) and must be adequately drained from food contact surfaces before contact with food, as required by 21 CFR 178.1010. Your response stated that (b)(4) levels will be monitored at points of contact to the processing line and a permanent solution is being investigated to replace the use of (b)(4). Your response did not include a timeframe for when you expect to have and implement a permanent solution to prevent sanitizer from directly contacting food.

2. You must have a HACCP plan that at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plan for pasteurized vacuum-packaged RTE surimi-based seafood analog products (sticks and shreds) is not adequate in that it lists a critical limit of “All finished Labels and case Labels must contain a "Keep Frozen Statement’” at your “Casing/Labeling” critical control point (CCP) for the hazard of “C. Botulinum & toxin formation during finished product storage”. Because your HACCP plan uses freezing and labeling as the control for Clostridium botulinum (C. botulinum) growth and toxin formation, you must have controls to ensure your products are immediately and rapidly cooled and frozen after vacuum packaging and pasteurization. Nonproteolytic C. botulinum can grow at a minimum temperature of 38°F and will grow rapidly when temperatures exceed 70°F. However, our investigator observed your firm holding your pasteurized vacuum-packaged RTE surimi-based seafood analog products in a walk-in cooler observed to be at 44-45°F for up to two days before freezing. Additionally, temperature records for this walk-in cooler indicated temperatures were 3.5°C (38.3°F) and above for over 150 times from February 26, 2020, to March 3, 2020, with some deviations lasting 3-4 hours and a maximum temperature of 24°C (75.2°F).

In lieu of a control strategy of freezing and labeling to control C. botulinum, your HACCP plan at the pasteurization CCP could list critical limits for the critical factors established by a scientific study necessary to achieve a 6-log reduction of type B nonproteolytic C. botulinum along with a CCP for finished product refrigeration at 40°F or below. Currently, your pasteurization CCP lists the hazard of L. monocytogenes which is less heat resistant than C. botulinum.

Your response stated that you have revised your HACCP plans and included new critical control points and copies of your hazard analysis; however, your revised HACCP plans were not included with your response. Your response also stated that maintenance was performed on your refrigeration unit, and you have increased temperature monitoring and included visual checks. However, your response did not include monitoring records; therefore, it is not clear if you have implemented these activities.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation and the Current Good Manufacturing Practice regulation (21 CFR 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You should take prompt action to correct the violations cited in this letter. Failure to do so may result in regulatory action without further notice including, without limitation, registration suspension, seizure and injunction.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please send your reply to the Food and Drug Administration, Attention: Tracy K. Li, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021- 4421. If you have any questions regarding this letter, please contact Ms. Li at (425) 302-0428.


Miriam R. Burbach
District Director
Program Division Director

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