| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human Services
December 7, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 12- 13
Nay Hla
President and Chief Executive Officer
Sushi Avenue, Inc.
895 Blue Gentian Road, Suite 6
Eagan, Minnesota 55121-1570
Dear Mr. Hla:
We inspected your seafood processing facility located at 895 Blue Gentian Road on July 12-14, 19-20, 2011, and August 9, 11, 18, 2011. We received your letter on September 8, 2011, responding to FDA-483 Inspectional Observations issued on August 18, 2011, at the conclusion of this inspection. Your response has been made a part of the Minneapolis District's permanent file for your firm.
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 and 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 Hawaii Roll, Nigiri Combo, Chef's Special, Sushicado, Tempura Shrimp Roll, Volcano Roll, Sushi Avenue Combo, Sunshine Combo, Tuna Spicy Roll (with and without brown rice),
Shrimp Spicy Roll (with and without brown rice), Salmon Spicy Roll (with and without brown rice), Shrimp Spring Roll, Sashimi Combo, Rainbow Roll 3, Rainbow Roll 2, Philly Roll (with and without brown rice), Nigiri Combo 3, California Roll (with and without brown rice), and Black Pepper Roll products 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 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."
a. However, your firm's HACCP plans for "Wild Frozen Raw Tuna" and "Frozen Raw Yellowtail" do not list the food safety hazard of pathogen growth.
b. Also, your firm's HACCP plans for "Frozen Cooked Real Crab Meat," "Cooked Squid," "Frozen Cooked Tempura Shrimp," "Frozen Imitation Crab Meat," "Frozen Imitation Crab Stick," "Smoked Salmon," "Squid Salad," and "Frozen Raw Yellowtail" do not list pathogen growth as a hazard at the Packaging Labeling critical control point.
2. You must implement the monitoring procedures and frequency that you have listed in your "Wild Frozen Raw Tuna" HACCP plan to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures of product temperature at the Thawing critical control point, and internal temperature of ready-to-eat (RTE) items at the Cooling of RTE Items critical control point to control Scombrotoxin formation listed in your HACCP plan for all products containing raw tuna. For example:
a. During the inspection, management stated that the temperature of RTE sushi rolls is taken with an (b)(4)
b. Also, records reviewed during the inspection document that you are monitoring the temperature of (b)(4) rather than the internal temperature of the product.
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 Scombrotoxin formation when your process for "Wild Frozen Raw Tuna" deviated from your critical limit at the Thawing and Cooling of RTE Items critical control points. For example:
a. On 7/20/11 the temperature of raw tuna stored in the reach-in cooler was (b)(4)F. Corrective action was not taken.
b. On 8/9/11 temperatures of Black Pepper Rolls containing raw minced tuna ranged from (b)(4)F to (b)(4)F. Corrective action was not taken to address this temperature deviation.
4. 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 plans for "Frozen Cooked Real Crab Meat," "Cooked Squid," "Frozen Cooked Tempura Shrimp," "Frozen Imitation Crab Meat," "Frozen Imitation Crab Stick," "Smoked Salmon" and "Squid Salad" list critical limits at Thawing, Packaging Labeling, and Cooling of RTE Items. These critical control points are not adequate to control pathogen growth. Specifically, the plans list a critical limit of (b)(4)F or less for internal temperature of the product.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and for enjoin your firm from operating.
We also note the following:
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines as "major food allergens" 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 the exception of highly refined oils. 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 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 (e.g. "(wheat)"), 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)].
Your Hawaii Roll, Nigiri Combo, Chef's Special, Sushicado, Tempura Shrimp Roll, Volcano Roll, Sushi Avenue Combo, Sunshine Combo, Tuna Spicy Roll (with and without brown rice), Shrimp Spicy Roll (with and without brown rice), Salmon Spicy Roll (with and without brown rice), Shrimp Spring Roll, Sashimi Combo, Rainbow Roll 3, Rainbow Roll 2, Philly Roll (with and without brown rice), Nigiri Combo 3, California Roll (with and without brown rice), and Black Pepper Roll product labels include "Contains" statements. However, the statements are not printed immediately after or adjacent to the list of ingredients.
You should respond in writing within 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 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). 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 Food and Drug Administration, Attention: Rebecca L. Caulfield, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612) 758-7194.
Sincerely,
/S/
Elizabeth A. Waltrip
Acting Director
Minneapolis District
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