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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Computer Times Publishing Inc. dba Sushi Chef 2/12/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone (510) 337-6700

 

UNITED PARCEL SERVICE 
DELIVERY SIGNATURE REQUIRED
 
 
WARNING LETTER
 
 
February 12, 2013
 
Our Reference #  100057778
 
Dean M. Matsushima, President/CEO
Computer Times Publishing, Inc.
dba Sushi Chef
500 Kuwili Street Suite #100
Honolulu, Hawaii 96817
 
Dear Mr. Matsushima:
 
We inspected your seafood processing facility, located at 500 Kuwili Street, Honolulu, Hawaii between September 11 and September 21, 2012. 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 (21 CFR 123) and the Current Good Manufacturing Practice Regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 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 refrigerated, ready-to-eat tuna sandwiches and sushi seafood products containing cooked tuna are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
 
Our inspection of your facility also revealed multiple violations of FDA’s Current Good Manufacturing Practice (GMP) regulations (21 CFR Part 110) related to foods other than fishery products. These violations make your ready-to-eat closed-faced chicken salad and egg salad sandwiches, sushi, and various rice and bento productsadulterated under section 402(a)(4) of the Act, in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health [21 U.S.C. § 342(a)(4)].
 
Additionally, our review of the labeling for your Futomaki 8PC and Ham & Cheese Sandwich 7 oz., revealed that these products are misbranded within the Section 403 of the Act and the regulations contained within 21 Code of Federal Regulations Part 101 (21 CFR 101). You may find the Act, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance and all other regulations through links in FDA's home page at www.fda.gov.
 
The deviations listed in this letter are based on the inspection and our review of your firm’s HACCP Plans for refrigerated, ready-to-eat Tuna Sandwiches entitled “Sandwich / Wraps” and Sushi containing tuna entitled “Sushi” that were collected during the inspection.
 
Your significant violations are as follows:
 
Seafood HACCP  

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,

a.  Your firm’s HACCP plan for “Sandwich/Wraps” that includes your tuna sandwiches does not list the food safety hazard of scombrotoxin (histamine) formation.

b.  Your firm’s HACCP plans for “Sandwich/Wraps,” containing tuna and wheat, and “Sushi,” containing fish (tuna and imitation crab), egg, crustacean (shrimp), milk, wheat, and soy, do not list the food safety hazard of undeclared allergens and food intolerance substances such as sulfating agents and colorings.  

We acknowledge that your firm did not consider allergens in your Hazard Analysis Worksheets as a potential hazard likely to occur and justified your decisions by stating allergens are controlled by your firm’s Sanitation Standard Operating Procedures (SSOPs) and Allergen Control program. However, FDA regulations require that all food safety hazards associated with a seafood product be addressed in your HACCP plan. Pre-requisite programs such as SOPs and GMPs cannot be used as a substitute. 
 
Please refer to Chapter 7 (Scrombrotoxin (Histamine) Formation and Chapter 19 (Undeclared Major Food Allergens) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition (the Fish Guide) for guidance in determining the appropriate controls for your process.
 
2.  You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However,  
 
a.  Your firm’s HACCP plans for “Sandwich/Wraps” that includes your tuna sandwiches and “Sushi” do not list the critical control point of mixing ingredients and Staging/Sorting for controlling the food safety hazard of pathogen growth and toxin formation as a result of time/temperature abuse in these ready-to-eat products.
 
To control pathogen growth as a result of time and temperature abuse during unrefrigerated processing in ready-to-eat seafood products such as your tuna sandwiches and sushi products, FDA recommends critical limits as specified on page 234-235 of the Fish Guide. For example, the product is held at internal temperatures below 50º F (10º C) throughout processing, or alternatively, the product is held at air temperatures below 50º F (10º C) throughout processing.   If at any time the product is held at internal temperatures above 50º F (10º C) but never above 70º F (21.1º C), exposure time at internal temperatures above 50º F (10º C) should be limited to 5 hours (12 hours for Staphylococcus aureus as the only pathogen of concern).
 
b.  Your firm’s HACCP plans for “Sandwich/Wraps” and “Sushi” do not list a critical control point for finished product storage to control the food safety hazard of pathogen growth. These products are ready-to-eat and must be stored under refrigerated conditions in the finished form to maintain the safety of the product. FDA recommends that firms include a critical control point for refrigerated products such as your ready-to-eat sandwiches, wraps and sushi. Moreover, FDA recommends the use of a continuous temperature-recording device (e.g. a recording thermometer) to monitor finished product storage, with a visual check of the recorded data at least once per day.
 
c.  Additionally, your product flow diagram for your sushi products indicates that raw materials used in your sushi products such as “fish/shellfish/imitation crab” are frozen with a subsequent thawing step. FDA recommends that firms include a thawing critical control point for ready-to-eat products to control pathogen growth as result of time/temperature abuse during the thawing cycle. We again recommend the use of a continuous temperature-recording device (e.g. a recording thermometer) to monitor the thawing step, with a visual check of the recorded data at least once per day.
 
Please refer to Chapter 12 (Pathogenic Bacteria and Toxin Formation) of the Fish Guide for additional information and guidance in determining the appropriate controls for your process.
 
3.  You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However,
 
a.  your firm’s HACCP plan for “Sandwich/Wraps” lists a monitoring procedure/frequency at the “Chill Storage” critical control point that is not adequate to control pathogen growth. Specifically, your monitoring to ensure the Storage Temperature is less than or equal to 40ºF by the “(b)(4)” at a frequency of “(b)(4)” is not adequate.   FDA recommends the use of a continuous temperature-recording device (e.g. a recording thermometer) for refrigerated storage, with a visual check of the recorded data at least once per day.
 
b.  your firm’s HACCP plan for “Sushi” lists a monitoring procedure/frequency
 
i.  at the “Chill Storage” critical control point that is not adequate to control pathogen growth. Specifically, your monitoring to ensure the Storage Temperature is less than or equal to 40ºF by the “(b)(4)” at a frequency of “(b)(4)” is not adequate. FDA recommends the use of a continuous temperature-recording device (e.g. a recording thermometer) for refrigerated storage, with a visual check of the recorded data at least once per day.
 
ii.  at the “Mix With Sushi Vinegar” critical control point that is not adequate to control pathogen growth. Specifically, monitoring “(b)(4)” as listed in your plan does not ensure that each batch of rice achieves the listed critical limit for (b)(4). Your firm should monitor each batch.
 
iii.  at the “Receiving” critical control point that is not adequate to control pathogen growth for RTE products received refrigerated (i.e., not frozen). Your critical limits are listed as “(b)(4)”. Your monitoring procedures describe (b)(4) with no monitoring associated with the temperatures of the products. Your monitoring procedures must reflect monitoring that adequately corresponds to your critical limits. In this case, your firm should adopt monitoring procedures associated with temperature monitoring. In addition, FDA recommends monitoring product temperatures only when transit times are short, such as transit times less than 4 hours. When transit times exceed 4 hours, FDA recommend obtaining documentation at receipt to demonstrate the products were properly maintained under refrigerated conditions for the entire duration of the transit period. This would include obtaining the continuous monitoring records of the transit vehicle.  
 
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following specific areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
 
A)  Safety of water that comes into contact with food or food contact surfaces, or is used in the manufacturer of ice [21 CFR 123.11(b)(1)]
 
Our investigators observed that your firm lacks a back-flow prevention device on the hose valve for the water hose used in the Sushi Room and this hose was stored on the floor near standing water. 
 
B)  Condition and cleanliness of food contact surfaces [21 CFR 123.11(b)(2)]
 
i) On September 13, 2012, our investigators observed residue of chopped boiled eggs on the blades and in the bowl the buffalo chopper used to chop celery and onions as an ingredient in tuna salad sandwiches. This bowl was allegedly cleaned the previous night and then used to chop celery and onion without further cleaning and sanitizing before use.
 
ii) On September 11, 2012, our investigators observed that the spatula used for mixing the filling for tuna salad, chicken salad, and egg salad sandwiches were not being washed or sanitized prior to use.
 
C)  Prevention of cross-contamination [21 CFR 123.11(b)(3)]
 
i)  On September 13, 2012, our investigators observed an employee touching facial jewelry and entering and exiting the room with gloved hands but not washing hands or changing gloves before mixing the tuna salad intended to be used as an ingredient in ready-to-eat tuna salad sandwiches. 
 
ii) On September 11, 12, and 13, 2012, our investigators observed your employees not washing and sanitizing their hands before the start of work, after each absence from their work station, and during the manufacturing and assembly of the ready-to-eat tuna sandwiches and sushi containing tuna. For example, employees were observed touching the strip curtains and directly handling doors between rooms when entering and exiting. However, the employees did not wash their hands or change their gloves before returning to handle ready-to-eat food. The investigators saw trash cans brushing against the strip curtains while being dragged between rooms.
 
Food (Non-Seafood) GMPs
 
1.  All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 110.10(b). One method for maintaining cleanliness is to wash hands thoroughly, and sanitize, as necessary, in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. [21 CFR 110.10(b)(3)].  
 
a. On September 13, 2012, our investigators observed an employee pick up trash  from the ground and discarded it without thoroughly washing and sanitizing his hands before proceeding to mix a batch of rice flour and water in the manufacturing of mochi. This employee was also observed touching the doors with his hands while he left the room and returned to immediately mix the mochi slurry with his bare hands without first washing his hands.
 
b. On September 11, 12, and 13, 2012, our investigators observed your employees at their workstations in the Rice Room, Sushi Room, and Bento Room talking on their cellular phones and immediately returning to work without first washing and sanitizing their hands. One employee was observed handling cooked rice intended for use in ready-to-eat sushi, one employee was observed handling mochi, and one employee was observed assembling ready-to-eat packaged food.
 
2.  All food-contact surfaces, including utensils and food-contact surfaces of    equipment, shall be cleaned as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). However, on September 13, 2012, our investigators observed leftover residue of chopped boiled eggs on the blades and in the bowl of the buffalo chopper used to chop celery and onions as an ingredient in chicken salad sandwiches and egg salad sandwiches. This bowl was allegedly cleaned the previous night and then used to chop celery and onion without further cleaning and sanitizing before use.
 
Label Review
 
During the inspection, our investigator also collected labels for several of your products. Our review of the labels and other evidence collected during the inspection found deviations from the labeling regulations that cause your “FUTOMAKI 8PC” and “Kona Bill’s Café Express Ham & Cheese Jumbo Sandwich Wheat Bread” products to be adulterated within the meaning of Section 402 of the Act [21 U.S.C. § 342] and misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343].  
 
1.  Your “FUTOMAKI 8PC” product is adulterated within the meaning of section 402(a)(2)(C) of the Act [21 U.S.C. § 342(a)(2)(C)] in that it contains aspartame as a sweetener agent but the label fails to bear the statement “PHENYLKETONURICS: CONTAINS PHENYLALANINE” on the principal display or information panel as required by 21 CFR 172.804(d)(2). The requirement for aspartame containing product labels to bear this statement is a condition of use for aspartame. Failure to provide this statement on the label of an aspartame-containing product makes the product adulterated.
 
2.  Your “FUTOMAKI 8PC” product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 USC § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive’s listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR 74.705(d)(2)]. Your product is manufactured with the ingredient “pickled radish” (TAKUAN) which contains FD&C Yellow #5; however, the label for the finished product fails to declare the presence of FD&C Yellow #5 in the ingredient statement.
 
3.  Your “FUTOMAKI 8PC” product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product bears or contains an artificial flavoring, coloring, or chemical preservative. In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients.  Your product is manufactured with “pickled radish” (TAKUAN) ingredient containing certified color additive FD&C Yellow #5 and the preservative potassium sorbate, as well as “pickled ginger” (RED GINGER) which contains certified color additive FD&C Red #40 and the preservative potassium sorbate; however, the product label does not identify the presence of the color additives and chemical preservatives with a separate declaration of its function. Under 21 CFR 101.22(k)(1), certified colors must be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term "No." (e.g., Yellow 5). In addition, chemical preservatives must be declared by its common or usual name with a separate declaration of its function in accordance with 21 CFR 101.22(j).
 
4.  Your “Kona Bill’s Café Express Ham & Cheese Jumbo Sandwich Wheat Bread” and “FUTOMAKI 8PC” products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. For examples:
 
  • During the inspection, your “Kona Bill’s Café Express Ham & Cheese Jumbo Sandwich Wheat Bread” product was observed being manufactured with lettuce and mayonnaise; however, you fail to declare the ingredients and sub-ingredients on the finished product label (wheat bread and mayonnaise are multi-ingredient foods).
 
  • Your “Kona Bill’s Café Express Ham & Cheese Jumbo Sandwich Wheat Bread” product label lists “HIGH FRUCTOSE OR LIQUID SUCROSE” and “MAY CONTAIN SESAME SEED” in the ingredient statement. The regulations do not allow for the use of terms such as “or” and “may contain” in your ingredient statement.  The ingredient statement must be an accurate list of only the ingredients that are used in the product’s manufacture.
 
  • Your “Kona Bill’s Café Express Ham & Cheese Jumbo Sandwich Wheat Bread” declares natural vegetable oil as an ingredient but fails to list the specific components of the oil ingredient. Under 21 CFR 101.4(b)(14), each individual fat and or oil ingredient of a food intended for human consumption must be declared by its specific common or usual name (e.g., “beef fat,” “cottonseed oil”) in its order of predominance in the food except that blends of fats and/or oils may be designated in their order of predominance in the foods as “____ shortening” or “blend of ____ oils,” the blank to be filled in with the word “vegetable,” “animal,” “marine,” or combination of these, whichever is applicable if, immediately following the term, the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., “vegetable oil shortening (soybean and cottonseed oil).” The term vegetable oil," on its own, is not a proper common or usual name because it does not list the common or usual name of each component fat or oil, as required by 21 CFR l0l.4(b)(14).   
 
  • Your “FUTOMAKI 8PC” product declares “KAMPYO”, “TAKUAN” and “RED GINGER” in the ingredient statement. These ingredients are multi-component ingredients; however you fail to list their sub-ingredients on the finished product label.
 
  • Your “FUTOMAKI 8PC” product lists “tamago” as ingredients; however based on information provided during the inspection your product does not contain this ingredient.
 
The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. 
 
5.  Your “Kona Bill’s Café Express Ham & Cheese Jumbo Sandwich Wheat Bread” and “FUTOMAKI 8PC” products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that they fail to bear a nutrition facts panel as required by 21 CFR 101.9.
 
To determine whether your firm is eligible for an exemption from certain nutrition labeling requirements, you can review nutrition labeling exemptions at 21 CFR 101.9(j). In addition, for information on nutrition labeling exemptions for small businesses, you can review the FDA webpage at: http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/SmallBusinessNutritionLabelingExemption/default.htm.
 
6.  Your “Kona Bill’s Café Express Ham & Cheese Jumbo Sandwich Wheat Bread” product is misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the package fails to declare the net quantity of contents, as required under 21 CFR 101.105.
 
7.  Your “FUTOMAKI 8PC” product is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the package does not contain the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
 
We may take further action if you do not promptly correct these violations.  For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating. 
 
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 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 noncompliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific things you are doing to correct these violations.  You should include in your response documentation such as copies of any revised HACCP plans, at least five (5) product days worth of HACCP monitoring records to demonstrate that you have implemented the revised plans, any verification records, copies of revised labels for the products that your firm manufactures and distributes, and other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations.  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Please send your reply to the attention:
 
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
 
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer at 510-337-6793.
                                                                                    
Sincerely,
/S/ 
Barbara J. Cassens
San Francisco District Director   
      
 
cc: Dilip Shrivastava, Owner
Computer Times Publishing, Inc.
dba Sushi Chef
500 Kuwili Street Suite #100
Honolulu, Hawaii 96817