K & S Wholesale Meat, 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

January 13, 2010

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Refer to MIN 10 - 08

Joseph A. Mazzara

General Manager

K & S Wholesale Meat, Inc.

1140 Wilburn Road

Sun Prairie, Wisconsin 53590

Dear Mr. Mazzara:

We inspected your seafood processing facility located at 1140 Wilburn Road, Sun Prairie, WI, 53590, on September 16, 17, 24, 28, 2009. 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). 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 are 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 shrimp to control the food safety hazard of undeclared sulfites on finished product labels; and your firm does not have a HACCP plan for breaded shrimp, breaded whiting fillets, breaded Pollock fillets, breaded ocean perch fillets, breaded clam strips, breaded cod fillets, breaded haddock fillets and crab cakes to control the hazard of undeclared food allergens on finished product labels. FDA recommends that controls be in place to assure that the presence of these ingredients (i.e. sulfites for sulfite-treated shrimp; and allergenic substances such as wheat, soy, milk, crustaceans, fish, and eggs in your breading and batter) are accurately declared on the finished product labels.

• 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 control records for the safety of water that comes into contact with food or food contact surfaces, the storage and handling of toxic chemical, and the control of employee health. Moreover, our investigator found your firm had not completed sanitation monitoring records for several months.

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 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/

W. Charles Becoat

Director

Minneapolis District

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