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WARNING LETTER

Fuji Food Products, Inc. MARCS-CMS 598233 —


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

Recipient:
Recipient Name
Mr. Farrell Hirsch
Recipient Title
President and CEO
Fuji Food Products, Inc.

14420 Bloomfield Ave.
Santa Fe Springs, CA 90670
United States

Issuing Office:
Office of Human and Animal Food Operations East Division 1

United States


WARNING LETTER
CMS # 598233

February 19, 2020


Dear Mr. Hirsch:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) seafood processing facility, Fuji Food Products, Inc. located at 121 Liberty Street, Brockton, MA 02301-5518, on November 12, 2019 through December 4, 2019. During our inspection, we collected environmental samples (i.e., swabs) from various areas in your processing facility, including food-contact surfaces and areas that are near food and food-contact surfaces. 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 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 our inspectional findings, including review of your HACCP plan and environmental testing, we have determined that your RTE sushi rolls and seafood poke bowls 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 have 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 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 investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. We acknowledge your firm’s responses dated December 17, 2019, December 26, 2019, January 17, 2020, and February 7, 2020, which included a description of corrective actions taken by your firm. We have reviewed the documentation 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 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 laboratory analysis of the environmental sample INV1122051 collected on November 12, 2019, during the production of RTE sushi rolls, confirmed thirty-two (32) of (b)(4) environmental swabs collected positive for L. monocytogenes. Of the positive findings, ten (10) swabs were collected from food-contact surfaces which include the cutting beds on your sushi roll cutters; the cutting knives situated below the cutting bed on your sushi roll cutters; the roll portioning/cutting knife that cuts the assembled and formed sushi roll; the hard-white plastic surface that holds the assembled and formed sushi roll; and the white out-feed conveyor belt surfaces. Additionally, twenty (20) swabs were found positive for L. monocytogenes on areas directly adjacent to food contact surfaces in your main processing room.

Furthermore, this was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for L. monocytogenes. Environmental sample INV1097530 collected on April 22, 2019, confirmed seven (7) of (b)(4) swabs collected positive for L. monocytogenes. Of these positive findings, five (5) swabs were collected from food contact surfaces which included your sushi cutting machines and conveyor belt.

Whole genome sequencing (WGS) was conducted on thirty-two (32) L. monocytogenes isolates obtained from the FDA environmental sample collected on November 12, 2019 and seven (7) L. monocytogenes isolates obtained from the FDA environmental sample collected on April 22, 2019. The current WGS analysis determined that the isolates derived from the samples collected at your facility during the two inspections referenced above represent a single strain of L. monocytogenes, indicating the presence of a resident pathogen since at least April 2019. We advised you of those WGS results via a conference call on December 12, 2019.

The reoccurring presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens on your processing equipment and in your facility to prevent contamination of food. 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. 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. 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. 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.

We acknowledge your December 17, 2019 and December 26, 2019, responses outlining the corrective actions you have taken in response to our L. monocytogenes environmental samples. We acknowledge that when you were initially made aware of our environmental findings you conducted a voluntary recall, ceased all manufacturing operations, and disposed of any product, including packaging, that had been opened from its packaging or otherwise exposed to the production environment, including all finished product and work in progress product. Additionally, you have retained consultants to assist in performing a root cause investigation and developing plans for implementing the appropriate corrective actions; are working to conduct a deep clean of your facility; are working to enhance your sanitation and environmental monitoring programs; are working to conduct facility repairs which include addressing the hygienic design of your sushi rolling machines and replacing certain components; are working to prepare plans to reduce condensate; are planning to perform environmental testing on food contact surfaces to verify your corrective actions; and are planning to perform extensive employee training on your updated programs and procedures.

You have committed to ceasing operations until your corrective actions have been implemented; you stated that you will provide the Agency updates every 15 business days on your progress in executing these corrective actions; and you stated that you will notify the Agency prior to resuming operations to allow the Agency to address any outstanding concerns.

Additionally, we acknowledge your January 17, 2020 and February 7, 2020, responses which summarized a proposed shift to your business structure in where upon resuming operations your Brockton facility will no longer manufacture, process, package, repackage, or engage in any other activities whereby food is exposed to the facility environment. Your Brockton facility will be exclusively used as a food storage warehouse/holding facility for ambient, refrigerated, and frozen human food. Your corrective actions also stated that you are engaging in deep cleaning and conducting environmental swabbing, revising personnel traffic patterns within the facility, and updating your cGMP procedures for the distribution areas of the facility. You have also provided details of these corrective actions including results of your environmental testing and indicated that copies of your new procedures will be shared with the Agency prior to resuming operations. Finally, you stated that if in the future your facility reconsiders this approach and decides to resume food production, they will not do so without first notifying FDA, modifying your facility registration to reflect the revised scope of operations, and taking appropriate actions to ensure you have engaged in comprehensive corrective actions to address FDA’s findings.

We acknowledge your proposal to resume operations as a food warehouse and possibly in the future resume food production. However, we still have concerns about the resident strain of L. monocytogenes that was found in your facility and the possible resumption of exposed food processing. Additionally, you have proposed moving some of your processing equipment to your Santa Fe Spring, California facility. The Agency would like to make you aware that your deep cleaning and sanitizing procedures should be aggressive to eradicate any L. monocytogenes harborage areas so that you do not contaminate your Santa Fe Springs facility with the same L. monocytogenes strain. Based on the above described isolation of a resident strain of L. monocytogenes from thirty-two (32) areas in your facility which included ten (10) food contact surfaces, we have concerns with your ability to address these findings and maintain a sanitary environment. Therefore, your firm should continue to provide evidence that the resident strain of L. monocytogenes has been eradicated from your facility and processing equipment.

We acknowledge your submitted corrective actions, and while you have provided a lot of documentation of your corrective action to date to address our findings, we have on-going concerns with your ability to maintain a sanitary environment given these findings. Specifically, we encourage your firm to provide documentation for your updated programs and procedures, as well as records demonstrating implementation of sanitary procedures. This would include your revised warehouse cGMPs, revised warehouse sanitation procedures for floors and drains, revised employee training program and procedures, and photographs of repairs to food processing equipment and HVAC systems. We recommend that you continue to implement corrective actions to ensure that L. monocytogenes does not contaminate your facility. The adequacy of your firm’s implementation of these corrections will be assessed during our next inspection.

Seafood HACCP

Your significant deviations are as follows:

1. In accordance with 21 CFR 123.11(b), 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. However, your firm did not monitor the following with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B:

A. Condition and cleanliness of food contact surfaces (21 CFR 123.11(b)(2)) and design, material, and workmanship of equipment and utensils makes them adequately cleanable (21 CFR 117.40(a)). FDA investigators observed:

i. Worn and frayed edges on the sushi manufacturing roll machine (b)(4) white conveyor belt used to transfer the ready-to-eat products to an employee for placement on metal trays. FDA environmental swabs of this conveyor belt were found positive for L. monocytogenes (swabs # 50 and 53 collected from the conveyor belt food-contact surface and swab # 52 collected from the underside of this conveyor belt).

ii. Cracks and missing pieces were observed on the blue plastic finished product conveyor belt of sushi roll packaging line #1, during the packaging of California Roll with use by date 11/22/19.

Your firm’s corrective action responses address the immediate concerns in that you have ordered new conveyor belts to be installed after the facility has been deep cleaned. In addition to replacing the belts, when processing you must monitor the condition of the belts with sufficient frequency to ensure that they are adequately cleanable (i.e., good condition) and are properly cleaned and sanitized. We will verify the adequacy of these corrective actions during our next inspection.

B. Prevention of cross-contamination from insanitary objects to food, food packaging material and other food contact surfaces (21 CFR 123.11(b)(3) and taking effective measures to protect finished food from contamination (21 CFR 117.80(c)(6)). FDA investigators observed:

i. Apparent over-spray from an employee that was spraying water onto the floor in the “blue room,” a refrigerated product storage area, was observed to saturate the following;

1. The exterior packaging of RTE ingredients including:

    a. Toasted sesame seed, 80/20 manufacturer lot 200300-TNM-255-19.
    b. Fujisan sushi seasoning, production date 8/16/19.
    c. Swiss cheese sauce SWCHEESE_NGMO_8, Production date 10/29/19.

2. Non-RTE ingredient, Homai, California brown rice.

ii. Cleaning and sanitizing operations were being performed for sushi rolling machines #1 and #2 in an area immediately adjacent to the manufacturing, processing and packing of RTE products including shrimp spring rolls on line #4. There was inadequate separation of sanitation activities from processing activities to prevent cross contamination from aerosolized overspray. In addition, swabs # 33, 39, 45, 46, 47, and 48, all collected from sushi rolling machines (b)(4) were found positive for L. monocytogenes.
iii. A trigger style water sprayer used in the cleaning operations of the sushi roll machine was observed between uses being placed on the ground. Additionally, there were multiple layers of white tape and/or plastic around the base of the sprayer.
iv. A trigger style water sprayer was observed hanging on a rack partially over a colander that contained multiple processing utensils. The hose attached to the spray handle was partially on the ground. The trigger style sprayer had multiple layers of black tape and/or plastic around the base.

C. Protection of food, food packaging material, and food contact surfaces from adulteration with condensate (21 CFR 123.11(b)(5)) and plant must be constructed in such a manner that condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials (21 CFR 117.20(b)(4)). FDA investigators observed:

i. During the manufacturing of spicy surimi mix, a component of your spicy California rolls with use by date 11/22/19, significant condensation was observed accumulating on the bottom of the cooling unit drip pan directly above the processing table, product scale and food contact bin in the prep room. This condensate was observed dripping onto the processing table, product scale and food contact bin. FDA swab # 67 collected from the floor drain near this dripping condensate and the processing table was found positive for L. monocytogenes. Dripping condensate is a repeat observation from our previous inspection which concluded on April 30, 2019.
ii. Condensation was also accumulating on the drip pan drain pipe in the prep room. This pipe passes directly above the (b)(4) used in manufacturing spicy surimi mix that was a component of your spicy California rolls with use by date 11/22/19. FDA swab # 68 from the floor wall junction directly below this condensation accumulation was found positive for L. monocytogenes. Dripping condensate is a repeat observation from our previous inspection which concluded on April 30, 2019.

Your firm’s corrective action responses address the immediate sanitation concerns as well as outlining long term corrective actions that you plan on implementing, including consulting with a third-party expert to assist in assessing how to implement better condensate control within your environment and implementing corrective action measures based on your findings. In addition to these actions, when processing you must monitor conditions with sufficient frequency to ensure employee practices prevent cross-contamination from insanitary objects, including over-spray and that food, food packaging material, and food contact surfaces are protected from adulteration with condensate. We will verify the adequacy of these corrective actions during our next inspection.

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,

A. Your firm’s HACCP plan for “Fully cooked fresh sushi/ seafood products/ shrimp products” lists critical limits of “Temperature Refrigerated products: (b)(4)” and “Refrigerated Shellfish /Fish: (b)(4)” at the “Receiving (refrigerate/refrigerated seafood and frozen products)” critical control point that are not adequate by themselves to control the food safety hazard of pathogenic bacteria growth and toxin formation, including Clostridium botulinum (C. botulinum) growth and toxin formation, as a result of time and temperature abuse during transit of refrigerated

seafood products. Relying on internal temperatures alone, taken at the time of receipt, does not ensure the products were continuously held under adequate refrigeration temperatures throughout transit to your facility. We recommend your critical limits list that refrigerated seafood is maintained at 40°F or below, or below 38°F for control of nonproteolytic C. botulinum, throughout transit using a continuous temperature recording device.

B. Your firm’s HACCP plan for “Fully cooked fresh sushi/ seafood products/ shrimp products” lists critical limits of “All labels should come with correct allergenic profile stated on it as required on the finished product packages. Should be verified with the master label document” at the “Receiving packing and labels” critical control point that is not adequate by itself to control the food safety hazard of undeclared major food allergens. Specifically, during our inspection we found your firm manufactures seafood products that contain one or more of the major food allergens including crustacean shellfish (e.g., crab or shrimp), Eggs, Fish (e.g., finfish in surimi, salmon, anchovies), Soy, and Wheat. The critical limits in your HACCP plan do not ensure that finished products are properly labeled. We recommend that your critical limit also ensure the finished products are appropriately labeled with the correct allergen declarations.

Your firm’s corrective action responses included a revised Warehouse HACCP plan dated 2/6/20. However, this revised HACCP plan lists the inadequate corrective action of taking the internal temperature of two (2) products when a temperature deviation occurs at your refrigerated storage critical control point. FDA recommends that the affected product be chilled and held until a food safety evaluation of the cumulative time and temperature exposure is conducted. Thus, a copy of a revised Warehouse HACCP plan and monitoring records should be submitted for our review. We will then verify your implementation of the revised HACCP plan during our next inspection.

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.

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 (21 CFR Part 123) 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.

Additionally, 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 noncompliance 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 re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). The inspection noted in this letter identified noncompliance 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: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, 462 Welcome Center Road, Swanton, VT 05488. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or by email at scott.loughan@fda.hhs.gov.

Sincerely,
/S/

Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1