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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fujiya Sushi Concepts, Inc. 10-Sep-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration
Dallas District Office
4040 N. Central Expressway
Suite 300
Dallas, Texas 75204

September 10, 2001
Ref 2001-DAL-WL-36
WARNING LETTER
Certified Mail
Return Receipt Requested

Mr. John W. Wester
President
Fujiya Sushi Concepts, Inc
P.O. BOX 161163
Austin, Texas 78716-1163

Dear Mr. Wester:

We inspected your seafood operation at 9030 Wurzbach Rd., San Antonio, Texas, on August 14, 16, 20 and 22 2001, and found that you have serious deviations from Title 21 of the Code of Federal Regulations (21 CFR) Part 123. These deviations cause your seafood products to be in violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find this Act and the Seafood HACCP regulations through links in FDA?s homepage at www.fda.gov.

Our inspection revealed your processing of seafood products deviates from the regulations contained in 21 CFR Part 123 as follows:

  • You must have a HACCP plan that lists the critical control points, to comply with 21 CFR 123.6 (c) (2). However, your firm?s HACCP plan for ready-to-eat sushi does not list the critical control points for controlling the food safety hazards of color additives (FD&C Yellow No. 5) and pathogen growth and toxin formation. These critical points include labeling receipt, pH and storage of the cooked rice, thawing and cooler storage of the frozen raw and cooked seafood and staging of the finished sushi products.
  • You must have a HACCP plan that lists the critical limits that must be met, to comply with 21 CFR 123.6 (c) (3). However, your firm?s HACCP plan for ready-to-eat sushi does not list critical limits for time, temperature and pH values for the referenced critical control points to control the identified hazards.
  • You must have a HACCP plan that lists the verification procedures and frequency that you will use in accordance with 21 CFR 123.8 (a), to comply with 21 CFR 123.6 (c). However, your firm?s HACCP plan verification sections do not include calibration of thermometers for the cooler storage and pH meters for the rice preparation critical control points.
  • You must maintain complete sanitation control records that document monitoring and corrections, to comply with 21 CFR 123.11 (c). However, your firm?s sanitation monitoring records were not complete during the period of 4/01/01-8/31/01.

Additionally, your HACCP plan should specify your firm name and address and be signed and dated by the most responsible person on site. Monitoring records should also be reviewed, signed and dated within one week.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. At the conclusion of the inspection your firm was issued a Form FDA-483 which is a list of the Investigators? observations of deviations noted during the inspection. A copy of the FDA-483 is enclosed. It is your responsibility to ensure adherence to each requirement of the Act and regulations.

You should know that this serious violation of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to seizure, and/or obtaining a court injunction against further marketing of your seafood products.

It is necessary for you to take action on this matter now. Please let this office know in writing within fifteen (15) working days from the date you receive this letter what steps you are taking to correct the problems. We also ask that you explain how you plan to prevent these violations from happening again. If you need more time, let us know why and when you expect to complete your corrections. Your reply should be sent to Gwendolyn Sue Gilbreath, Compliance Officer, at the above address.

Sincerely,
Michael A. Chappell
Dallas District Director