Inspections, Compliance, Enforcement, and Criminal Investigations
ICH Group, LLC dba Sushi Chef 24-Aug-04
Department of Health and Human Services
Public Health Service
San Francisco District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Our Reference: FEI 1000577785
August 24, 2004
Kenneth H. Iong, Chief Executive Officer
ICH Group, LLC dba Sushi Chef
500 Kuwili Street, #100
Honolulu, Hawaii 96817
Dear Mr. Iong:
On July 19, 20, 21, and 22, 2004, the United States Food and Drug Administration (FDA)inspected your seafood processing facility located at 500 Kuwili Street, #100, Honolulu, Hawaii. We found that you have a serious deviation from the seafood Hazard Analysis and Critical Control Points (HACCP)regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 223). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of this part, renders the processor's fish and 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 refrigerated, ready-to-eat fishery products, e.g. sushi and nigiri, 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 FDA's Fish & Fisheries Products Hazards & Controls Guidance, Petition, June 2001 through links in FDA's homepage at www.fda.gov. We listed the deviation on a Form FDA 483 and discussed them with Glenn A. Wong, President, at the conclusion of the inspection. We are enclosing a copy for your reference. Your serious deviation was:
You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control any food safety hazards that are likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for refrigerated, ready-to-eat fishery products, specifically sushi and nigiri, to control pathogen growth and toxin formation as a result of time/temperature abuse.
You must immediately take appropriate steps to correct the violation. We may take further action if you do not promptly correct the violation. For instance, we may take further action to seize your products and/or enjoin your firm from operating. Please respond in writing within fifteen (15) working days of receipt of this letter. Your response should outline the specific, things you are doing to correct the violations. You may wish to include in your response documentation such as copies of your HACCP plan, HACCP monitoring records, or other useful information that would assist us in evaluating your corrections: If you cannot complete all corrections before you respond, we expect that you will 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 regulations and the Current Good Manufacturing Practices [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 directed to: Ms. Erlinda N. Figueroa, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have any questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District