Garden-Fresh Foods, 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

February 3, 2010

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Refer to MIN 10 - 10

Thomas Hughes

President

Garden-Fresh Foods, Inc.

726 South 12th Street

Milwaukee, Wisconsin 53204

Dear Mr. Hughes:

We inspected your seafood processing facility located at 726 South 12th Street, Milwaukee, Wisconsin, 53204, on November 16-19, 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 (21 CFR 123). 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 Tuna Salad, Shrimp Scampi Dip, Creamy Seafood Salad containing shrimp and surimi, and Smoked Salmon Dip 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 & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. 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 Seafood Salad Products does not list the critical control point of thawing/storage of vacuum-packed surimi to control the food safety hazard of pathogen growth and potential toxin formation, specifically Clostridium botulinum growth and toxin formation. Your hazard analysis failed to identify Clostridium botulinum growth and toxin formation as a hazard during the thawing of the unopened frozen vacuum-packed surimi. Your thawing process takes a significant period of time which could result in Clostridium botulinum toxin formation in the absence of time and temperature controls.

2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for Seafood Salad Products does not list an appropriate monitoring frequency at the Storage of Finished Products critical control point to control pathogen growth. Your HACCP plan states "Temperature checks are performed at a minimum of (b)(4) at this critical control point. Intermittent temperature monitoring cannot provide an equivalent safety assurance that unsafe conditions have not occurred between those intermittent checks.

FDA recommends continuous time/temperature monitoring of storage conditions for refrigerated ready-to-eat seafood products.

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 Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 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

xc: Mohammad Elahi

Vice President, Operations

Garden-Fresh Foods, Inc.

726 S. 12th Street

Milwaukee, WI 53204

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