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U.S. Department of Health and Human Services

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Enforcement Actions

Uwajimaya, Inc. 16-Feb-07

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

Public Health Service
Food and Drug Administration

 

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone:425-486-8788
FAX: 425-483-49996





February 16, 2007


VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 07-09


Akira Moriguchi, President
Uwajimaya, Inc.
4601 Sixth Avenue South
Seattle, Washington 98108


WARNING LETTER

Dear Mr. Moriguchi:

We inspected your facility, located at 651 South Industrial Way, Seattle, Washington, on October 4, 5, and 6, 2006. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123) and the Current Good Manufacturing Practices (cGMP) requirements for foods, 21 CFR Part 110. 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 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 herring roe on kelp, scombroid seafood, and ready to eat sushi products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, we also found deviations from the cGMPs relating to flour and cake mix products in the bakery production area that rendered those products adulterated within the meaning of Section 402(a)(4) of the Act in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth. You can find the Act, the Seafood HACCP regulation, the cGMP regulation, and the FDA Fish and Fisheries Products Hazards and Controls Guidance through links in FDA's homepage at www.fda.gov.

Your significant deviations were as follows:

1. 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 the following five areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110:

a. Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments, 123.11(b)(2), as evidenced by

  • Product residue was observed on the surface of one processing table and inside one automatic sushi rolling machine located in the sushi room, after cleaning and sanitizing.

  • One section (approximately 4" long) of a blue plastic strainer used to drain uncooked rice was observed cracked and torn.

  • As a result of poor welding, sections of a stainless steel wash basin used to wash uncooked rice contain deep grooves and pockets which are un-cleanable and thus promote microorganism growth.


b. Prevention of cross-contamination from insanitary objects to food,food packaging material, and other food contact surfaces, 123.11(b)(3), as evidenced by an employee making ready-to-eat sushi rolls was observed touching the lid of a blue plastic insulated cooler containing product residue and filth, then touching imitation crabmeat, then touching a wooden handle of a knife, and then touching the rice as she completed making the sushi roll, without washing and sanitizing her hands or gloves.

c. 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, 123.11(b)(5), as evidenced by

  • An employee observed applying a foam detergent to food contact surfaces, walls; and the floor in the sushi room. One opened container of mayonnaise was stored on a table while this detergent was being, applied to the same table it was located on, in addition to the walls behind this table.

  • Employees observed rinsing floors with hoses in the rice room and sushi room. Floor splash from the hoses was observed to come within inches of direct contact with rice and in direct contact with plastic totes, plastic strainers, and knives which come in direct contact with the ready-to-eat sushi:

  • Cooked, ready-to-eat rice observed cooling near a fan. A layer of dust/dirt was observed on the front grill of this fan, which was blowing directly onto the rice.

  • Condensate was observed dripping from the ceiling in the deli cooler where ready-to-eat food is stored

  • [redacted] mixer used in the bakery room observed with chipped paint on the mixer head and thick product residue encrusted on the surface under the rotating arm. There was in process bakery product directly below these areas.


d. Proper labeling, storage, and use of toxic chemicals, 123.11(b)(6), as evidenced by two bottles containing cleaning chemicals were observed on the floor and under the sink in the sushi room. One bottle was unlabeled and the labeling of the second bottle was partially torn and could not be deciphered

e. Exclusion of pests from the food plant, 123.11(b)(8), as evidenced by:

  • One live warehouse beetle larvae observed inside a 50# paper bag of cake flour, stored in a covered plastic bin in the bakery room.

  • At least.four fruit flies were observed flying inside a plastic container storing raisins in the bakery processing-area.

  • Live warehouse beetles (3 adults and 3 larvae) were also observed on the surface of 50# bags of flour {Cake; Whole Wheat, Gluten, and White) stored on four pallets located along the east wall in the raw material storage area of the warehouse.

  • Three additional live warehouse beetle larvae were observed in flour residue on a wall ledge located directly behind this plastic storage bin.

  • Three additional live warehouse beetle larvae were observed on and around equipment stored in the direct vicinity of this area.

  • One adult fly was observed in flight in the bakery processing area:

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 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 plan for Uwajimaya and Cho Cho Brand Sushi does not list critical control points (CCP) for:

a. Finished product refrigerated storage for controlling the food safety hazards of pathogen growth and toxin production, and

b. Product preparation for controlling the food safety hazard(s) of growth and toxin production relating to pathogens and toxin formation. This was evidenced during the inspection when the FDA Investigator observed two containers of cooked, Ready to Eat, vacuum packaged shrimp on the processing table. These shrimp were to be used in the preparation of-sushi Shrimp Rolls. The ambient temperature in the sushi preparation room was noted on the(FDA or the Firm's wall mounted) thermometer as 49°F. The FDA Investigator determined that these two containers of shrimp had been in this processing room for four hours.

3. 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 plan for Uwajimaya and Cho Cho Brand Sushi lists a critical limit of "Cooler/freezer temperatures cannot exceed [redacted]°F for [redacted] hours" at the raw material "Storage of Filling Mixture" critical control point-that is not adequate to control pathogen growth and toxin formation. Based on the way your critical limit is stated, products could be stored at temperatures and times that would allow pathogen growth and toxin production; for, example [redacted]°F for [redacted] hours and [redacted] minutes, and still be within your critical limit.

FDA recommends.that cooler storage temperatures, be maintained at 40 °F or below.

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 all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the cGMP regulation. 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: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Donovan at (425) 483-4906.

Sincerely,

/S/

Charles M. Breen
District Director


Enclosures: Form FDA 483


cc: WSDA with disclosure statement