Sivertson Fisheries Inc

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7194 FAX: (612) 334-4142

 

June 1, 2010

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 Refer to MIN 10 - 15

Richard R. Martin

President and Owner

Sivertson Fisheries Inc. dba Lake Superior Fish Company

15017 North First Street

Superior, Wisconsin 54880

Dear Mr. Martin:

We inspected your seafood processing facility located at 1507 North First Street, Superior, WI, on January 27-28, 2010. 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 and 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 pickled herring and air-packed, ready-to-eat smoked fish products 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 and Controls Guidance through links on FDA's home page at www.fda.gov.

Your significant violation is as follows:

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 a HACCP plan for ready-to-eat Pickled Herring to control the food safety hazards of scombrotoxin (histamine) formation and pathogen growth. You do not have a HACCP plan for ready-to-eat smoked fish including Smoked Lake Herring (Cisco and/or Tullibee) to control the hazard of pathogen growth.

For additional information and guidance in developing a HACCP plan, please refer to the Fish and Fisheries Products Hazards and Controls Guidance, Third Edition (the Hazard Guide).

We may take further action if you do not promptly correct this violation. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

You should 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 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 123) and the Current Good Manufacturing Practice regulation (21 CFR 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: Rebecca L. Caulfield, Compliance Officer, at the address on this letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612)758-7194.

Sincerely,

/S/

Howard E. Manresa

Acting Director

Minneapolis District

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