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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Seattle Fish Company, Inc. 08-Sep-05

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

Public Health Service
Food and Drug Administration


Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, KS 66214-3340
Telephone: (913)752-2100

September 8, 2005



Ref. KAN 2005-14

Mr . Edward Iacino, President
Seattle Fish Company, Inc.
6211 E. 42nd Avenue
Denver, CO 80216

Dear Mr. Iacino:

On May 31, 2005 through June 10, 2005 we inspected your seafood processing facility, located at 2800 Guinotte Avenue, Kansas City, Missouri. 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 123). 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 fish products, such as tuna, mahi-mahi and wahoo are adulterated, in that these products 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. You may find the Act and the Seafood HACCP Regulations through links in FDA's home page at www.fda.gov.

The deviations were as follows:

You must have a HACCP plan that lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for histamine forming fish lists a monitoring frequency of twice daily for monitoring of the temperature at the "Cooler Storage" CCP that is not adequate for the control of histamine formation. FDA recommends continuous monitoring of temperature or periodic monitoring of the adequacy of ice if the product is stored on ice in the cooler.

You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of water that comes into contact with food and the prevention of cross-contamination from insanitary objects to food as evidenced by:

1. Dirt and grime inside your ice machine.

2. A water hose used for cleaning was observed on the floor

3. Fish residues on the cutting boards, processing tables, knives, fish scrapers and scales.

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.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations . You should include in your response documentation such as corrective action records, revisions to the HACCP plan 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 deviations.

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 Regulations and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Joseph G. Kramer, Compliance Officer, 11630 West 80th Street, Lenexa, KS 66214-3340. If you have any questions regarding any issue in this letter, please contact Mr. Kramer at (913) 752-2719.



John W. Thorsky
District Director
Kansas City District