• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

Enforcement Actions

World Sushi Express, Inc. 13-Aug-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Los Angeles District

19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900


WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

August 13, 2007

W/L 16-07

Phillip T. Phan, President
World Sushi Express, Inc.
3033 Clairemont Drive
San Diego, CA92117

Dear. Mr. Phan:

We inspected your seafood processing facility, located at 3033 Clairemont Drive, San Diego, CA 92117 on June 21-26, 2007. 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 I10 (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 refrigerated and ready-to-eat sushi items including Spicy Tuna Roils and Spicy Salmon 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 a`s follows:

1. You must implement the record keeping system that you listed in your HACCP plans, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm has not recorded any monitoring observations/data listed in your HACCP plans [redacted]

2. You must conduct a hazard analysis 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 critical control point, 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, your firm's HACCP plans for sushi products containing raw salmon and raw tuna do not list the critical control point of rice acidification to prevent the growth and toxin formation of pathogens Bacillus cereus and/or Staphylococcus aureus during processing and holding of the rice used to make sushi rolls.

3. You must conduct a hazard-analysis 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 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, your firm's HACCP plans for [redacted] each do not list the critical control point of "thawing" (i.e., under refrigeration) to control the food safety hazard of pathogens. In addition, your firm's HACCP plan for [redacted] does not list the critical control point of [redacted] to control the food safety hazard of pathogens.

4. 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 (1) Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product; (2) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by:

  • On 6/21/0Z employees were eating and drinking while seated at a food contact surface processing table; the employee's food and drinks were placed directly on the processing table during this meal. This same area of the processing table was then used to prepare sushi rollers for production by covering the rollers in plastic wrap; the table was not cleaned and sanitized prior to this use. In addition, there was a partially consumed beverage in a plastic container on another processing table in your kitchen.

  • On 6/21/07 there were two soiled vent screens directly above your rice cookers.

  • On 6/21/07 two hoses on a soap / sanitizer dispenser at your three-compartment sink extended below the fill level of the sinks. The soap / sanitizer dispenser is connected directly to your processing water system; there is no visible back-flow prevention device on the dispenser or to the attached processing water plumbing.

5. 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 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for: (1) Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; (2) Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; (3) Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product; (4) Maintenance of hand washing, hand sanitizing, and toilet facilities; (5) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; (6) Proper labeling, storage, and use of toxic compounds; (7) Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and (8) Exclusion of pests from the food plant, that are required for the processing of Spicy Tuna Rolls and Spicy Salmon Rolls that are ready-to-eat fishery products manufactured by your firm.

We may take further action if you do not promptly correct this violation. 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 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.

Your written reply should be addressed to:

Pamela B. Schweikert, Director, Compliance Branch
U. S. Food and Drug Administration
19701 Fairchild
Irvine, California 92612-2445

If you have questions regarding any issue in this letter, please contact Robert McNab, Compliance Officer at (949) 608-4409.

Sincerely,

/S/

Alorta E. Cruse
District Director

cc: State of California, DHS/FDB
Department of Health Services
Food and Drug Branch
P.O. Box 997413, MS-7602
Sacramento, CA95899-7413