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RESPONSE LETTER

Northwest Frozen, LLC dba Banzai Sushi


Company:
Northwest Frozen, LLC dba Banzai Sushi

Northwest Frozen, LLC dba Banzai Sushi
3623 6th Avenue South, Suite 200
Seattle, Washington 98134-2200

March 29, 2017

FDA
Seattle District Office
ATTN: Jessica Kocian
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021
Re: FDA Warning Letter WL SEA 17-07

Dear Mrs. Kocian:

Please find below Northwest Frozen LLC’s (NWF) corrective actions and comments for the violations in Warning Letter SEA 17-07. NWF’s responses are below each FDA violation and in bold:

1. 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for “Frozen IQF Sushi Pieces” does not list the following food safety hazards:

a. Clostridium botulinum growth and toxin formation: Intact vacuum-packaged seafood products are placed in the walk-in cooler overnight for sushi production the following day. Your Storage Temperature Log lists acceptable refrigerator temperatures as “(b)(4)°F < temp=""><>(b)(4)°F.” Our review of your Storage Temperature Logs for the walk-in cooler reveal multiple excursions at or above 40 degrees Fahrenheit and up to 44 degrees Fahrenheit between May 2015 and December 2016. Vacuum-packaged product in which refrigeration is the sole barrier to outgrowth of non-proteolytic C. botulinum should be maintained below 38 degrees Fahrenheit. Further, FDA recommends continuous monitoring during storage, using a continuous temperature-recording device (e.g., a recording thermometer), with a visual check of the recorded data at least once per day.

NWF response: As a corrective action, NWF has changed the defrost algorithm to ensure that temperatures during defrost do not exceed 38°F. Please find attached Addendum 1a for 2017 year to date temperature graph as evidence. Per SOP 047, the acceptable temperature range for NWF coolers is (b)(4)F < temp="">< 38°f.="" see="" addendum="" 2="" to="">

NWF would like to clarify the FDA finding of “multiple excursions at or above 40 degrees Fahrenheit and up to 44 degrees”. The FDA does not include the time of each temperature excursion, a critical variable in the growth of clostridium botulinum. These “excursions” were due to refrigeration defrost cycles. NWF’s cooler goes into 30 minute defrost cycles (b)(4) times per day which may cause the ambient cooler temperature to temporarily rise. We have validated that the temperatures of products stored in the cooler do not materially increase during these defrost cycles.

NWF would also like to clarify the implication of the FDA recommendation of “continuous monitoring during storage, using a continuous temperature-recording device (e.g., a recording thermometer), with a visual check of the recorded data at least once per day”. This statement wrongfully suggests that NWF does not currently use continuous recording temperature devices nor visually inspects cooler temperatures. For several years NWF has and continues to equip its refrigeration assets with continuous temperature recording devices. These devices are calibrated (b)(4) per Calibration Program SOP 016. All truck and rail shipping vessels containing NWF finished products are also equipped with (b)(4) based temperature recorders to ensure the cold chain from NWF to the end-customer. In fact, NWF designed its own proprietary (b)(4) temperature recorders because no commercially viable units were available. This is a significant investment and, to date, NWF is aware of few other food manufacturers with full real-time visibility of the entire cold chain. NWF also has and continues to perform documented visual temperature checks (b)(4) per day.

b. Pathogenic bacteria growth and toxin formation: In-process surimi to be used in sushi was observed stored in the walk-in cooler throughout the processing day.

NWF Response: See response to 1(a).

c. Undeclared Allergens: Fish, soy, milk, wheat, egg, and shellfish used in your finished product sushi rolls are major food allergens.

NWF response: NWF Allergen Program is an oPRP (operational prerequisite program) which includes measures to fully control the risk of undeclared allergens. NWF believes its Allergen Program should be an oPRP and not a CCP because its Allergen Program is a prerequisite program and does not contain monitoring activities with critical limits. All finished product labels are reviewed, inspected for correctness, and documented in LOG 004 before being released into production. NWF performs First Article Inspections at the beginning of each production run to verify label correctness. Further, NWF performs documented random allergen specific swab tests sensitive to (b)(4) ppm to verify the effectiveness of its Sanitation Program.

2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces, prevention of cross contamination, and protection from adulterants with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:

a. (b)(4) machines were observed in the production area and your firm’s management stated that cooked, ready-to-eat (RTE) shrimp used to make RTE sushi rolls is placed into nylon mesh bags and (b)(4) in order to remove moisture from the shrimp. Your firm’s management stated that the (b)(4) machine is not disassembled for cleaning. Debris was observed covering one of the holes in the metal drum of the machine.

NWF response: This machine has since been discontinued and replaced with a (b)(4), fully sanitizable machine. See Addendum 2(a) for picture of new machine.

NWF would like to clarify that the machine referenced in this violation was previously approved by the FDA. In 2014, NWF responded to an FDA audit observation by purchasing said machine. The FDA subsequently sent a representative from the Washington State Department of Agriculture to inspect the machine. The representative inspected the machine and stated “NWF will be contacted if there are any further concerns.” NWF received no further communication from either the FDA or Washington State Department of Agriculture and thus reasonably assumed the said machine was appropriate for its purpose.

b. Plastic strip curtains above the “S” belt, used to convey sushi trays into (b)(4) for freezing, were visibly soiled and observed in direct contact with uncovered trays of sushi. Plastic strip curtains hanging in the opening of the freezer were visibly soiled and observed in direct contact with RTE sushi on a metal cart being wheeled into the freezer.

NWF response: The curtains have been removed from the “S” belt area to avoid potential contact with sushi. Racks containing sushi are now covered before being wheeled into freezer.

c. Packing tape of approximately four inches by three inches was observed visibly soiled and adhered to the food contact surface of a metal mixing table used to hold RTE sushi fillings and toppings.

NWF response: As part of NWF GMP’s, tape and related temporary repairs are not permissible. During the FDA audit, the tape was immediately removed from the mixing table and the responsible individuals were retrained. See Addendum 2(c).

d. The conveyor belt for the (b)(4) machine that is a food contact surface for the sushi rolls was observed with food buildup between the crevices of the belt and debris on the underside of the belt after being cleaned and sanitized.

NWF response: Belt was immediately re-cleaned and the sanitation leads were retrained. See Addendum 2(d).

e. A metal mixing table used to hold RTE sushi fillings was observed being cleaned on its side in direct contact with the pitted floor.

NWF response: The part of the table that made contact with the floor was fully sanitized before reentering production. If any direct food contact surface makes contact with the floor (via dropping, etc), the surface is always fully sanitized. As a corrective action to this violation, NWF trained its sanitation crew to not tilt tables during sanitizing, as the tables are at risk of falling on their sides and making contact with the floor. See Addendum 2(e).

f. Employees were observed touching non-food contact surfaces, including the handle for the vinegar spout, a soiled rag, a pen used for pH monitoring, sides of rusted rice cooker bowls, and the inside of a trash can, prior to contacting RTE ingredients, including rice, avocado, and seaweed paper without changing or sanitizing their gloves.

NWF response: Corrective action was taken by retraining employees on proper changing of gloves. See Addendum 2(f).

g. Employees were observed entering the production area without washing their hands with soap and water prior to manufacturing RTE sushi. Employees were also observed entering the production area wearing their street shoes without using a foot bath.

NWF response: Employees were retrained on the proper use of the foot bath and hand sink outside the production area. The entrance into the production area has been redesigned to prevent employees from walking around the foot bath. See Addendum 2(g).

h. An employee was observed donning a previously used smock stored with other used smocks on top of employee lockers prior to entering the production area.

NWF response: NWF has redesigned a larger area for appropriate storage of smocks. Employees were retrained that smocks are not to be stored in or on lockers. See Addendum 2(h).

i. During sanitation, the (b)(4) machine and sushi line were observed splashed with water and debris from the floor by an employee using a squeegee.

NWF response: Final (b)(4) sanitation of food contact surfaces occurs after floors are cleaned. ATP swab tests are conducted on direct food contact surfaces to verify effective sanitation. As a preventative action, employees were retrained on use of squeegee and sanitation of machines. See Addendum 2(i).

j. Condensate on the ceiling of the walk-in cooler was observed above tables of RTE surimi, sections of which were uncovered and exposed. A piece of discolored ice fell from the cooler ceiling and landed on the plastic cling wrap covering RTE spicy crab.

NWF response: Products are always fully covered and protected when stored in the walk-in cooler, including the occurrence referenced in this violation. The cooler entered a defrost cycle which caused the condensate and ice to fall from an evaporator coil. As a corrective action, a daily inspection of the cooler ceiling and evaporator coils was added to LOG 017 “Production Area Daily”. If necessary, ceiling and coils are wiped down to prevent any condensate or ice build-up. See addendum 2(j).

k. Fans with visible dirt and dust were observed pointed in the direction of and in use within three feet of open containers of exposed RTE rice.

NWF response: Fan cleaning frequency was increased from (b)(4) to (b)(4) See addendum 2(k).

3. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the safety of water that comes in contact with food and food contact surfaces, the maintenance of hand washing, hand sanitizing, and toilet facilities, and the proper labeling, storage, and use of toxic compounds. Specifically, your “Production Area Daily,” “Monthly Sanitation Plan,” “Quarterly Sanitation Plan,” and “Annual Sanitation Plan” records do not contain documentation of the aforementioned sanitation controls.

NWF response: As a corrective action, “Safety of Water” was added to NWF’s LOG 017 “Production Area Daily”. See Addendum 3(a). Water safety has always been and is tested annually by a certified laboratory most recently on 11/17/2016. In addition, our water supplier, City of Seattle, provides an annual report on its water safety testing which is maintained in SOP 023, dated December 2016. The proper labeling, storage, and use of toxic compounds has been added to NWF’s LOG 017“Production Area Daily”. See Addendum 3(a). NWF uses (b)(4) in areas that are sanitized. Concentration (in ppm) is measured to ensure the chemical is effectively used. NWF’s Chemical Control Program contains details on proper handling and storage of all other chemicals in the facility.

It is NWF’s opinion that it has corrected and addressed all violations in Warning Letter WL SEA 17-07. NWF asks that the FDA review its corrective actions in an expeditious manner, as NWF does not believe this Warning Letter is indicative of the food safety of its products.

As the owner of Northwest Frozen LLC, I would like to go on record that I believe this Warning Letter contains several ambiguities that have caused my customers confusion. These ambiguities have had a damaging effect on my company. Additionally, as with all matters of food safety, my company took the findings of this FDA audit seriously and corrected the majority of the violations the same day of observation. A clarification of the ambiguities and a summary of my company’s corrective actions follows:

Violation 1(a) Cooler Temperature: There is no duration of time associated with the “multiple excursions” of temperature. A reader of this Warning Letter (including my customers) could assume that my company’s raw materials were stored at a dangerously high temperature for significant periods of time. This is false. These excursions were due to industry standard defrost cycles. There is no evidence that actual product reached a dangerously elevated temperature for any duration of time. There is also no record of the FDA agent recording elevated product temperatures during the inspection.

Violation 1(c) Undeclared Allergens: A reader of this Warning Letter could assume that my company has no allergen controls in place. This is false. My company’s HACCP program does contain a hazard analysis on all present allergens. Our Allergen Control Program (a prerequisite program as defined by the FDA) fully controls the chemical hazard of all present allergens. We therefore classify our Allergen Program as an oPRP, which we believe is widely accepted in industries adhering to certain GFSI schemes.

Violation 2(a) Shrimp Machine: My company made a good faith effort in 2014 to address this FDA observation from the 2014 FDA Audit. At that time, I was advised that the FDA or Washington State Department of Agriculture would contact me with any further concerns. I was never contacted and reasonably assumed my 2014 corrective action was accepted. In January of 2017, two weeks after the most recent FDA audit, we installed a new machine in response to the FDA observation.

Violations 2(b) – 2(k): All of these GMP violations were corrected on the same day of the FDA audit, two months before this Warning Letter was issued. My company has grown significantly over the past year and has hired team members from a diversity of cultures. This has increased the need for employee training. I am thankful the FDA observed these violations.

Violation 3(a) Water and Chemical daily checks: My company updated our Daily Sanitation Log 017 to include a daily water and chemical safety check before this Warning Letter was issued.
 

I believe my company’s prompt corrective actions and the ambiguities in the Warning Letter warrant an expeditious FDA response. I am eager to move past this correspondence and continue producing safe, wholesome, delicious, and affordable food!

Sincerely,
/S/

Phil Sinz
Managing Member

Northwest Frozen, LLC dba Banzai Sushi
3623 6th Avenue South, Suite 200
Seattle, Washington 98134-2200