| Public Health Service Food and Drug Administration |
New England District |
Department of Health and Human Services
NWE-14-11W
VIA UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
March 25, 2011
Mr. Hitoshi Okano
Central Manager
True World Food Boston, LLC
22 Foodmart Road
Boston, MA 02118-2802
Dear Mr. Okano
We inspected your seafood processing facility, located at 22 Foodmart Road on October 4, 5, 13, and 27, 2010. 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 raw refrigerated fluke; Nigiri; and sushi 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 in FDA's home page at www.fda.gov.
Your 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 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). However, your firm’s HACCP Plan # 6 – Primary Process for Fresh Ocean Harvested Fish for raw refrigerated fluke does not list the food safety hazard of parasites.
We are in receipt of your letter of December 2, 2010 and find that it does not address the lack of control for the food safety hazard of parasites for your raw refrigerated fluke process. You indicate that the HACCP plan collected during the inspection is for a “primary processor” only and that you are not a primary processor. However, control of parasites in raw ready-to-eat fish that pose a hazard for parasites is the responsibility of the final processor, who is the entity selling the fish directly for raw consumption, rather than the responsibility of the primary processor who supplied the fish. In addition, you should conduct a hazard analysis on all your fish and fishery products, including those listed in HACCP plan #2, to determine whether parasites are reasonably likely as a hazard that needs to be controlled.
2. 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 Nigiri and sushi products at the “Finished Product Storage” critical control point to control pathogens and histamine/scombrotoxin is not appropriate. Specifically, your plan lists that you will “move product to another cooler”. However, our inspection revealed that your firm has only one cooler consequently; you will be unable to implement this corrective action.
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.
We have the following additional comments with regard to your HACCP plans:
1. With regard to your firm’s HACCP plan for “Nigiri and Sushi Rolls”, you must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and include in your HACCP plan adequate critical control points to control those hazards. A review of your processing operations reveals that your firm will likely need to list the combined critical control points for manufacturing the rolls, including thawing of raw materials, ingredient preparation, assembly, rolling, cutting and packaging/labeling cumulatively to control the food safety hazards of pathogen growth and histamine (i.e., in the rolls containing scombroid species). FDA recommends limiting the cumulative time for manufacturing of the rolls, to control pathogen growth and histamine; or alternatively, controlling and monitoring the temperature of the processing room, to prevent pathogen growth and histamine development.
2. With regard to your monitoring procedures at the “Receiving Finished Product Label” critical control point in your HACCP plan for “Nigiri and Sushi Rolls”, the procedure listed as “label COC on file” is not appropriate as a control method for your listed hazard of “Food allergens/label accuracy”. Your firm should be monitoring the actual labels and not the certificate of compliance (i.e., COC). For example, your firm should be conducting a visual check of one label from each lot of labels when receiving those labels to ensure that all allergenic substances are accurately listed on the labels for each finished Nigiri and sushi product.
3. We note that your HACCP plans #3, #4 and #10 which are those plans that cover raw fresh (not frozen) vacuum packed fish, include references to the presence of time/temperature indicators (TTIs), as well the requisite 38°F as the temperature critical limit necessary for control of Clostridium botulinum toxin in raw fresh fish. However, we note that your monitoring procedures for receipt of these products involve the monitoring of the TTIs to ensure that the TTI devices have not flipped color, indicating temperature abuse. Please be advised rather than monitoring the condition/color of the TTIs at receipt, FDA recommends that firms monitor receiving temperatures to ensure that the products have not been exposed to temperatures above 38°F during transit. Consequently, we recommend that your firm adopt a procedure to ensure that temperatures were continuously maintained at or below 38°F during transit to your facility, via continuous monitoring of product temperatures or continuous monitoring of the transport vehicle’s refrigeration unit.
4. In addition, we note that your various HACCP plans list varying temperature critical limits for cooler storage. For example, some plans list cooler storage temperatures at 38°F, (b)(4). It was revealed, however, during our inspection that your firm has only one cooler. Consequently, we recommend that because you will be storing all products in the same cooler, you set the cooler temperature to meet the most stringent temperature limit, i.e., the lowest temperature, in order to ensure that those products that need more stringent temperature controls are maintained and stored under safe conditions. For example, we recommend that you set your cooler temperature at or below 38° F.
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.
Please send your reply to the Food and Drug Administration, Attention: Lori A. Holmquist, Compliance Officer, U.S. Food and Drug Administration, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at 207.622.8266 x13.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District
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