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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sushi Boy Inc 3/13/12

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax          (949) 608-4415 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED                                                           
 
 
March 13, 2012
                                                                                                                                                W/L 21-12
Mr. Masayoshi Yokota, President/Owner
Sushi Boy, Inc.
18527 S Broadway
Gardena, CA   90248-4632
 
Dear Mr. Yokota:
 
We inspected your seafood processing facility, located at 18527 S Broadway Gardena, California on November 16, 18 and December 6, 2011. 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 foods, Title 21, Code of Federal Regulations, Part 110 (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 ready-to-eat sushi products containing shrimp, tuna, and salmon are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
 
We acknowledge receipt of your written response dated December 20, 2011. We have reviewed your response, which included an updated HACCP plan, as well as corresponding records.  However, based on your response and your HACCP plan that was provided, your ready-to-eat sushi products continue to be adulterated. The significant violations are 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 your sushi products containing shrimp and histamine forming species such as tuna, does not list the food safety hazards ofundeclared sulfiting agents for shrimp and histamine formation (i.e. during refrigerated storage and thawing) for tuna.
 
Please refer to Chapter 7 and 19 of the Fish & Fisheries Products Hazards & Control Guidance, Fourth Edition for additional information related to controlling histamine formation, and undeclared allergens (i.e. sulfites).  
 
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, your firm’s HACCP plan for sushi products containing raw salmon, raw tuna and vacuum packed fishery products does not list the critical control point(s) of:
 
  •  “Receiving” for controlling the food safety hazard of pathogen growth and toxin formation in refrigerated salmon intended for raw consumption.
  •  “Storage” for controlling the food safety hazard of pathogen growth and toxin formation in your refrigerated salmon intended for raw consumption.
  •  “Thawing” (i.e. under refrigeration at less than or equal to 40ºF) for controlling the food safety hazard of pathogen growth and toxin formation for all ready-to eat fishery product ingredients other than vacuum-packaged raw products.
  •  “Thawing” (i.e. under refrigeration at less than or equal to 38ºF or open vacuum packages at refrigeration at less than or equal to 40ºF) for controlling the food safety hazard of Clostridium botulinum growth and toxin formation in your raw vacuum-packed fishery products such as raw tuna cube and raw ground tuna.
 
We acknowledge your response stating that you are now opening the vacuum packages when transferring product from your freezer for thawing. This should be included as part of your thawing critical control point for frozen raw vacuum-packed fishery products.
 
We also acknowledge your response stating that you have purchased and are now using a (b)(4) in your “3 door refrigerator” cooler as well as the “Walkin Refrigerator” temperature log you provided with your response. However, your revised HACCP plan still fails to include a storage critical control point for monitoring of your “3 door refrigerator” and “Walkin Refrigerator” storage coolers. Please refer to Chapter 12 of the Fish & Fisheries Products Hazards & Control Guidance, Fourth Edition for additional information related to refrigerated storage control.
 
3.    You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control “pathogens” when your sushi rice deviated from your critical limit of pH (b)(4) at the “rice mixing” critical control point. Specifically, your “pH Check Log” records for the month of May 2011 and June 2011 show that the pH readings for sushi rice were 4.39 on 5/30/11, 4.39 on 5/31/11, and 4.99 on 6/15/11. 
 
4.    You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations listed in your HACCP plan for sushi products. For example:
 
    1. Your firm did not record monitoring observations at the “Cooling” critical control point to control “Pathogens” listed in your HACCP plan for sushi products.  Your firm did not have monitoring records for the time period from 1/27/2011 to 11/16/2011. 
    1. Your firm did not record monitoring observations at the “Rice Mixing” critical control point to control “Pathogens” listed in your HACCP plan for sushi rice. Your firm could not provide “Sushi Rice Log” monitoring records for the time period from 7/01/2011 to 7/31/2011 and 10/01/2011 to 10/31/2011. 
    1. Your firm did not record monitoring observations at the “Package/Label” critical control point to control “Allergen” listed in your HACCP plan for sushi products.  Your firms package/labeling monitoring record dated 10/13/2011, 11/09/2011 and 11/12/2011 do not show that labels for your sushi products such as “Spicy Shrimp rolls”, “Dx Sushi Value Combo”, “Spicy Salmon lover” and “Spicy Tuna hand rolls” were reviewed. Also, your HACCP plan does not specify what the label is being compared with (i.e. product formula). Please refer to Chapter 19 of the Fish & Fisheries Products Hazards & Control Guidance, Fourth Edition for additional information related to control strategies for undeclared allergens (Table 19-9).
 
5.    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 sushi products lists a critical limit, (b)(4) for at least (b)(4), at the “Shrimp Cooking” critical control point that is not adequate to control the hazard of “Pathogens”.   Based on this critical limit, the period of time the internal temperature of the shrimp must be maintained does not appear adequate to control pathogens such as Listeria monocytogenes (L.monocytogenes).   Please refer to Table A-3 Appendix 4 of the Fish & Fisheries Products Hazards & Control Guidance, Fourth Edition. The times provided in Table A-3 are the length of time at the designated internal product temperature necessary to deliver a 6D kill process for L. monocytogenes. These values apply to all foods. You may be able to establish a shorter process time for your food by conducting scientific thermal death time studies. You should validate your cooking process to assure that your process will consistently attain the critical limits that you have set and adequately control the hazards listed in your plan.
 
In addition, your firm’s HACCP plan for sushi products lists a critical limit, (b)(4) within (b)(4)  hours”, at the “Cooling” critical control point that is not adequate to control the hazard of “pathogens”. Your critical limit does not take into account the cooling time between 135ºF to 70ºF. FDA recommends that the product be cooled from 135ºF to 70ºF within 2 hours and further cooled from 135ºF to 40ºF within an additional 4 hours.
 
6.    Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for your sushi products at the “Cooling”, “Shrimp Cooking”, and “Rice Mixing” critical control points to control “Pathogens” are not appropriate since your listed corrective action plan does not address the steps to be taken to ensure that the cause of the deviation is addressed.
 
In addition, your corrective action plan for your sushi products at the “Package/Label” critical control point to control “Allergens” is not appropriate since your listed corrective action plan does not address the steps to be taken to ensure that the cause of the deviation is addressed.
 
Additional Comments:
 
We also have concerns regarding your control of the hazard of parasites in your refrigerated salmon intended for raw consumption. The January 11, 2011 "Letter of Conformance" provided by the grower of the salmon you receive does not provide all the information needed to eliminate the parasite hazard. This letter states that salmon are raised in either open water net pens or land based operation facilities. Salmon raised for any part of their lifetimes in freshwater land-based operations can have a parasite hazard depending on where and how they are raised. In order to eliminate parasites as a hazard in your HACCP plan, you should have further information on the origin and culture of the salmon, or a more specific letter from the supplier assuring that the pellet-fed, pen-reared salmon were raised from eggs using techniques that prevented contamination with hazardous nematodes, trematodes, and tapeworms in a manner consistent with use for raw consumption. Although attaining detailed source information and implementing source control procedures may reduce the risk of parasites to a reasonable level, freezing is the best way to completely eliminate the risk of parasites in fish intended for raw consumption. Please provide information that explains how you are controlling the hazard of parasites in your salmon intended for raw consumption. For further guidance please refer to Chapter 5 of the Fish & Fisheries Products Hazards & Control Guidance, Fourth Edition for additional information related to controlling parasite hazards.
 
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.
 
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 HACCP and verification records, or 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, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Your response should be sent to:
 
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
 
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
 
Cc:     
Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, CA   95899-7413