Inspections, Compliance, Enforcement, and Criminal Investigations
Japanese Food Express, Inc. 13-Apr-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
April 13, 2006
Chang Sun, Manager
Japanese Food Express, Inc.
600 Biddle St.
Wyandotte, MI 48192
Dear Mr. Sun:
We inspected your seafood processing facility, located at 600 Biddle St., Wyandotte, Michigan on February 2 through March 8, 2006. 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 imitation crab meat and shrimp 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 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have HACCP plans for the following products:
a) Ready-to-eat imitation crab meat sushi rolls to control the food safety hazard of pathogen growth.
a) Ready-to-eat shrimp sushi rolls to control the food safety hazards of pathogen growth and sulfites (a seafood processing related hazard). Because the product is intended to be held at refrigerated (not frozen) temperatures, pathogen growth is a reasonably likely hazard. For more information on the pathogen hazard and sulfite hazard, please refer to Chapters 12 and 19, respectively, of FDA's Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.
We acknowledge receipt of your letter of response dated March 20, 2006. However, your letter did not address any of the observations listed on the FDA Form 483 and contained the same documents collected as exhibits during the inspection . These documents included a HACCP plan for "SUSHI RICE," along with a hazard analysis for the rice and guidance for its manufacturing practices. However, these documents did not cover the seafood ingredients. In addition, the manufacturing practice guidance and the hazard analysis indicated critical control points and quality critical control points (which we would suggest you consider as possible critical control points) that were not listed in the HACCP plan. For example, the HACCP plan did not include a cooling critical control point, an acidification critical control point or a refrigerated storage critical control point. All of which are listed in these documents and which would likely be necessary for pathogen control. In addition, there is no cook time at the cooking critical control point.
2). 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 conditions and cleanliness of food contact surfaces and prevention of cross contamination with sufficient frequency to ensure that adequate controls are being maintained.
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 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water that comes into contact with food or food contact surfaces, condition and cleanliness of food contact surfaces, prevention of cross- contamination from insanitary objects, 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 pests.
4) You must conduct cleaning and sanitizing operations for utensils and equipment in a .manner that protects against contamination of food, food-contact surfaces, and food-packaging materials to comply with 21 CFR 110.35(a). However, throughout the inspection, a heavy accumulation of dark brown-black material was observed adhering to the bottom shelf and legs of the two tables on wheels used to prepare and package finished ready-to-eat imitation crab meat and shrimp sushi roll products.
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.
This letter may not list. a11 the violations at your facility. You are responsible for ensuring that your processing pant 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: Paige E. Wilson, Compliance Officer at U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have questions regarding any issues in this letter, please contact Ms. Wilson at (313) 393-8250.
Joann M. Givens