Inspections, Compliance, Enforcement, and Criminal Investigations
Concept Asia Food Service LLC 3/29/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
March 29, 2012
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-19
Hyuna Chong, Owner
Concept Asia Food Service, LLC
1222 South Weller Street
Seattle, Washington 98144-2037
Dear Ms. Chong:
We inspected your seafood processing facility, located at 1222 South Weller Street, Seattle, Washington, on January 10, 2012, through January 26, 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, 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 sushi roll products, including the salmon roll, eel roll, tai roll, imitation crab roll, and tuna roll, 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 and Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. 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 your sushi rolls lists a critical limit of keeping the pH level “under (b)(4)” at the sushi rice making critical control point that is not adequate to control Bacillus cereus and Staphylococcus aureus.
The pH of (b)(4) is insufficient to control the hazard associated with post-cooking survival or re-contamination of the rice with pathogenic bacteria including Bacillus cereus and Staphylococcus aureus. The minimum survival pH for Bacillus cereus is 4.3 and for Staphylococcus aureus it is 4.0. You may find the information contained in Appendix 4 of the Fourth Edition of the Fish and Fisheries Products Hazard and Control Guidance useful in determining critical limits to control pathogenic bacteria growth.
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonable 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 do not list the critical control point of cooling after cooking for the food safety hazard of pathogenic bacteria growth. The rice is cooked for (b)(4) minutes, then ladled into plastic insulated sushi boxes with vinegar. The boxes are then placed in the cooler. Our investigator documented that the rice temperature was between (b)(4) and (b)(4) for (b)(4) hours. We understand that your intention is for the rice to stay warm in the insulated boxes for manipulation purposes; however, the timeframe observed is excessive.
b) Your firm’s HACCP plan for your tuna/spicy tuna roll does not list the critical control point of finished product storage for controlling the food safety hazard of histamine formation.
c) Your firm’s HACCP plans for your sushi rolls does not list the critical control point of finished product storage for controlling the food safety hazard of pathogenic bacteria growth.
3. 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 plans for your sushi rolls at the “Sushi rice making” critical control point to control pathogenic bacteria growth is not appropriate. For example your corrective action plans do not reference how you will correct the cause of the deviation or what the product disposition will be when products are found to have exceeded critical limits. Your corrective action plans as listed are also inadequate in that they indicate you will (b)(4) to meet the PH level” to meet the critical limit of “under (b)(4)” which, as we have already listed in this letter, is an inadequate critical limit.
4. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). Even though your critical limit is inadequate, it was also noted during the inspection that on at least 31 days, from January 2012 to March 2012, you exceeded your critical limit of “under (b)(4)” and you did not take any corrective action.
5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor with sufficient frequency:
a) The conditions and cleanliness of food contact surfaces including utensils, gloves, and outer garments, as required by 21 C.F.R. 123.11(b)(2), in that:
i) Employees were preparing sushi rolls with gloved hands and touching unsanitary surfaces, and then returning to food handling without changing their gloves.
ii) Several cleaned plastic trays were observed to have product residue or water droplets prior to placing unwrapped sushi rolls on them.
iii) After cleaning and prior to use, the large gas rice cooker was observed with buildup of product residue on the interior of the lid and rice was observed trapped under the lid gasket.
iv) The stainless steel measuring cups in the rice storage bins were soiled with product residue and hand prints.
b) The prevention of cross contamination from insanitary objects to food and other food contact surfaces, as required by 21 CFR 123.11(b)(3), in that:
i) Food particles, residue and/or grime were present during processing in the Sushi Make Room on the exterior, top, handles, interior sides and wire shelf supports of the sushi/sandwich bar and the (b)(4) machine interior cabinet, control panel and knobs.
ii) An employee had hair protruding from their hair net while preparing food.
iii) An employee was wearing unsecured earrings while preparing food.
iv) Personal beverage containers and personal belongings were present in the sushi making room during sushi production.
c) The proper labeling, storage and use of toxic chemicals, as required by 21 CFR 123.11(b)(6), in that a bottle of hand sanitizer and a spray bottle labeled “sanitizer” were stored on a shelf in the custard prep area adjacent to ingredient containers of cane sugar and above rice storage containers.
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 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 firm 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: Farhana Khan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issues in this letter, please contact Farhana Khan at 425-483-4968.
Charles M. Breen
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560