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  5. Northwest Frozen, LLC dba Banzai Sushi (Banzai) - 519343 - 03/20/2017
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Northwest Frozen, LLC dba Banzai Sushi (Banzai) MARCS-CMS 519343 —

Northwest Frozen, LLC dba Banzai Sushi (Banzai)

United States

Issuing Office:
Seattle District Office

United States



Black HHS-Blue FDA Logo



Seattle District Office
22215 26th Avenue SE, Suite 21 0
Bothell, Washington 98021 


March 20, 2017
In reply, refer to Warning Letter SEA 17-07
Philip K. Sinz, Owner and Managing Member
Northwest Frozen, LLC dba Banzai Sushi
3623 6th Avenue South, Suite 200
Seattle, Washington 98134-2200
Dear Mr. Sinz:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 3623 6th Avenue South, Seattle, Washington, from January 4, 2017, through January 13, 2017. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for food, Title 21, Code of Federal Regulations, Part 110[1] (21 CFR 123 & 110). 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). Accordingly, your fish and fishery product sushi rolls are adulterated, 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 FDA’s Fish and Fisheries Products Hazards & Controls Guidance through links on FDA’s home page at www.fda.gov.
Your significant violations were as follows:
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 (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.
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.
c.  Undeclared Allergens: Fish, soy, milk, wheat, egg, and shellfish used in your finished product sushi rolls are major food allergens.
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.
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.
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. 
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.
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.
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. 
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.
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. 
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. 
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.
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.
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. 
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in regulatory action being initiated without further notice, including, without limitation, seizure and/or injunction.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. 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 reinspection-related costs.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations, and to prevent these violations from recurring or other similar violations from occurring. You should include documentation of corrective actions you have taken to date. If your firm will not be able to complete corrective actions before you respond, please state the reason for the delay and include a timetable for implementation of those corrections.
Your firm’s response should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Jessica L. Kocian, Compliance Officer. Refer to the identification number WL SEA 17-07 when replying. If you have any questions regarding any issues in this letter, please contact Compliance Officer Jessica Kocian by telephone at 425-302-0444. 
Miriam R. Burbach
District Director
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560       
Olympia, Washington 98504-2560
Seafood Inspection Program
1315 East-West Highway
Silver Spring, Maryland 20910

[1] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.

Response Letter

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