Inspections, Compliance, Enforcement, and Criminal Investigations

Edo Sushi Express 12/29/15

  

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

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556
 
WARNING LETTER
 
CMS # 480917
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
                                                                        December 29, 2015
 
Cynthia L. Tun
President
Edo Sushi Express, Inc.
900 Main Street
Oakville, CT 06779-1999
 
                                                                                               
Dear Ms. Tun:
 
We inspected your seafood processing facility, located at 900 Main Street, Oakville, CT on September 9, 10, and 15, 2015. 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 seafood sushi rolls 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.
 
Your significant violations are as follows:
 
cGMP Violations:
 
1.    You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of visually checking the temperature of your recording (b)(4) at your (b)(4) critical control point (CCP) to control the hazards listed in your HACCP plan for ready- to-eat seafood sushi rolls.
 
For example, the “(b)(4)” CCP requires visual (b)(4) checks of the (b)(4) recorder monitoring data for critical limit (CL) deviations. You are only performing the visual checks but not checking the recording data for critical limit deviations. Also, this CCP requires a check of the accuracy of the time temperature recorder every day as part of your verification step. The check conducted by the monitoring employee includes only a visual check of the recorder digital display temperature.
 
We acknowledge your October 5, 2015 response to the FDA-483. We acknowledge that you have trained employees to check thermometers used at the firm and record readings appropriately. However, your response is unacceptable because it did not provide any documentation to indicate how you will assure that these deficiencies do not reoccur. 
 
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, your firm’s HACCP plan for ready-to-eat seafood sushi rolls does not list a critical limit at the (b)(4) critical control point to control for allergens.
 
Specifically, your firm's sushi roll HACCP plan (b)(4) CCP) does not include any provision for comparing finished product labels to source documents (e.g. product formulation, master label book) to insure that all allergens in product are declared in the finished product label. You manufacture (b)(4) different rolls, (b)(4) of these are seafood sushi rolls and require an allergy check. The monitoring employee should not be relying on memory as a method of checking for food allergens in all these products. 
 
We acknowledge your October 5, 2015 response to the FDA-483. However, your response is unacceptable because it did not provide any documentation, such as your revised HACCP plan or monitoring record to demonstrate this item has been corrected.
 
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 any sanitation monitoring records for the safety of water;  condition and cleanliness of food contact surfaces;  maintenance of hand washing, hand sanitizing, and toilet facilities;  protection of food, food packaging material and food contact surfaces from adulteration;  proper labeling, storage and use of toxic chemicals;  control of employee health conditions and exclusion of pets, required for the processing of ready-to-eat seafood sushi rolls from 4/1/15 to 5/12/15.
 
Also, there are no periodic (monthly) sanitation monitoring reports to document the safety of water, condition of food contacts surfaces and prevention of cross contamination.
 
Adulteration
 
1.    Your “Spicy Tuna,” “Spicy Salmon,” “Spicy Shrimp,” and “Spicy Combo” products are adulterated within the meaning of section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] in that they bear or contain a food additive which is unsafe within the meaning of section 409 of the Act. Specifically,
  • The “Spicy Tuna” and “Spicy Salmon” product labels declare aspartame as an ingredient; however, the labels fail to bear the statement “PHENYLKETONURICS: CONTAINS PHENYLALANINE” on the principal display or information panel as required by 21 CFR 172.804(d)(2).
  • The “Spicy Shrimp” product label declares aspartame as an ingredient followed immediately by “(contains phenylalanine);” however, this fails to meet the requirements of the phenylketonurics statement.
  • The “Spicy Tuna,” “Spicy Shrimp,” “Spicy Salmon Roll,” and “Spicy Combo” product labels declare sodium saccharin as an ingredient, but do not declare the amount of sodium saccharin per serving. Sodium saccharin may be safely used as a sweetening agent in food for a valid special dietary purpose in accordance with 21 CFR 180.37. Sodium saccharin may be used in processed foods as a sweetening agent in amounts not to exceed 30 milligrams of the additive, calculated as saccharin, per serving of designated size (21 CFR 180.37(d)(3)). The label of any finished product that contains sodium saccharin shall bear the name of the additive (21 CFR 180.37(f)(2)(i)), and for processed foods, the amount of sodium saccharin per serving, calculated as saccharin (21 CFR 180.37(f)(2)(ii)(c)).
 
Misbranding
 
1.    Your “Spicy Shrimp” and “Spicy Tuna” sushi roll products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergen; “eggs” as required by section 403(w)(1) of the Act.
 
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
  • The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or
  • The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
 
Specifically, your “Spicy Shrimp” and “Spicy Tuna” sushi roll product labels declare “eggs” in the contains statement; however, you fail to declare the source of the “eggs” in the ingredient statement.
 
2.    Your “Spicy Tuna,” “Vegetable Combo,” “Spicy Salmon,” “Spicy Shrimp,” and “Spicy Combo” sushi roll products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in an appropriate format as required by 21 CFR 101.9. For example,
  • The “Spicy Tuna” and “Spicy Shrimp” sushi roll product label fails to declare a serving size as required by 21 CFR 101.9(d)(3)(i) and 21 CFR 101.9(b)(7).
  • The “Spicy Salmon,” “Spicy Combo,” and “Vegetable Combo” sushi roll product labels fail to declare a serving size in a common household measure as required by 21 CFR 101.9(b)(7).
  • The product label fails to declare the number of servings per container as required by 21 CFR 101.9(b)(8) and 101.9(d)(3)(ii).
  • The product labels fail to declare calories from fat as required by 21 CFR 101.9(c)(1)(ii).
  • The product labels fail to declare transfat as required by 21 CFR 101.9(c)(2)(ii).
  • The product labels fail to declare Vitamin A, Vitamin C, Calcium, and Iron as required by 21 CFR 101.9(d)(8).
  • The product labels fail to declare the percent daily value (DV) in accordance with 21 CFR 101.9(d)(6).
 
You may qualify for the nutrition labeling exemptions for low-volume products found in 21 CFR 101.9(j)(18) if you employ fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product is sold in the United States in a 12-month period.
 
Your “Spicy Tuna,” “Spicy Shrimp,” “Spicy Salmon,” “Vegetable Combo” and “Spicy Combo” sushi roll products are misbranded within 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 and each ingredient is not declared on the label, as required by 21 CFR 101.4. For example,
  • Your products are manufactured using mayonnaise which is a standardized food under 21 CFR 169.140. However, you fail to list all the sub-ingredients on your finished product labels.
  • Your “Spicy Tuna” product label declares chili sauce, mustard, soy sauce, and fried onions in the ingredient statement; however, you fail to list the sub-ingredients on your finished product label.
  • Your “Spicy Shrimp” product label declares hot chili sauce, mustard, and fried onion in the ingredient statement; however, you fail to list the sub-ingredients on your finished product label.
  • Your “Spicy Salmon” product label declares chili sauce, mustard, and soy sauce in the ingredient statement; however, you fail to list the sub-ingredients on your finished product label.
  • Your “Spicy Combo” product label declares chili sauce and mustard in the ingredient statement; however, you fail to list the sub-ingredients on your finished product label.
  • The “Vegetable Combo” product label declares fried bean curd, mustard, and soy sauce in the ingredient statement; however, you fail to list the sub-ingredients on your finished product label.
 
According to 21 CFR 101.4(b)(2), 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, or by listing the component ingredients without listing the ingredient itself. 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.
  • Your “Spicy Salmon” and “Spicy Combo” product labels declare salmon in the ingredient statement; however, this is not the common or usual name of this ingredient in accordance with the Seafood List (see http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm453865.htm.
  • Your “Spicy Combo” product label declares “thiting” in the ingredient statement; however, this is not the common or usual name of a fish.
  • Your “Spicy Combo” product label appears to use a “shotgun” label approach in the declaration of ingredients; however, if fails to meet the guidelines under CPG Sec. 505.100 Bakery Products, Candy-Catch All or “Shotgun” Ingredients Declaration. While these products are not bakery or candy products, the use of a “shotgun” format would be applicable with sushi-type products if used in accordance with the CPG, specifically:
 
“Assortments in one package and all ingredients are not common to items in the assortments 21 CFR 101.100(a)(1)* permits such labeling when “in terms which are as informative as practical and which are not misleading.” In cases where such labeling is necessary, those ingredients common to all items should be listed first in the ingredient declaration followed by a listing of ingredients not common to all, including specific indications of which ingredients are actually present in designated articles. Few instances will defy such organization and with the possible exception of candy assortments the statement of identity in conjunction with the ingredient declaration must enable the consumer to tell exactly what is in each article of food.”
  • Your “Vegetable Combo” product label declares “inari” in the ingredient statement; however, this is not the common or usual name of an ingredient.
  • Your “Vegetable Combo” product label declares “hydrolyzed protein” in the ingredient statement; however, you failed to identify the food source of the protein in accordance with 21 CFR 101.22.
 
We acknowledge your October 5, 2015 response to the FDA-483. We will need to verify your corrective actions during a re-inspection of your facility,
 
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.
 
Comments:
 
  • The “Spicy Tuna,” “Spicy Shrimp,” and “Spicy Combo” product labels bear a “may contain” statement which is an “advisory statement. This statement could cause confusion to the consumer when purchasing the products since these products do in fact contain many of these major food allergens.
  • The “Vegetable Combo” product label declares “wheat” in the “Contains” statement; however, fails to declare wheat in the ingredient statement. The “Contains” statement must be adjacent to the ingredient statement.
  • The “Spicy Salmon” product label declares fish, egg, soy, and wheat in the “Contains” statement; however, fails to declare these ingredients in the ingredients statement. The declaration of “fish” does not meet the requirements under FALCPA. The “Contains” statement must be adjacent to the ingredient statement.
  • Your products are identified on the labels as “Vegetable Combo,” “Spicy Tuna,” “Spicy Shrimp,” and “Spicy Combo;” however, you fail to include “roll” or “sushi roll.”
  • For your “Spicy Combo” product, it is unclear as to whether or not all of the types of named sushi are packaged with this labeling at all times. If the product does not contain all four varieties at all times, then the name of the product would not clearly represent what is in the package.
  • All of your product labels fail to include the street address and zip code of the manufacturer, packer, or distributor; however, the street address may be omitted if it is shown in a current city directory or telephone directory (21 CFR 101.5(d)).
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
 
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.
 
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.
 
Please send your reply to the Food and Drug Administration, Attention: Diane M. Prince, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Ms. Prince at 781-587-7442.
 
Sincerely,
/S/
Joseph S. Matrisciano, Jr.
Acting District Director
New England District Office
 

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