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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Rainbow Springs LLC, dba Star Prairie Trout Farm 5/4/09

   

Department of Health and Human Services logoDepartment 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) 758-7132
FAX: (612) 334-4142

 

May 4, 2009

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 09 - 17

Timothy F. Madden
Owner, Rainbow Springs, LLC dba Star Prairie Trout Farm
Dungarvin Minnesota, LLC
690 S. Cleveland Avenue
St. Paul, Minnesota 55116

Dear Mr. Madden:

We inspected your seafood processing facility, Rainbow Springs, LLC dba Star Prairie Trout Farm, located at 400 Hill Avenue, Star Prairie, Wisconsin, on December 10, 11, 15, and 19,2008. 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), the Current Good Manufacturing Practice regulation for foods (21 CFR 110), and the Food Labeling regulations (21 CFR 101).

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and to implement a HACCP plan that complies with this section, or to 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 air packaged refrigerated smoked trout, air packaged refrigerated smoked salmon, vacuum packaged refrigerated smoked trout, vacuum packaged refrigerated smoked salmon, refrigerated raw trout packed in sealed plastic sleeves, and air packaged refrigerated smoked fish of unidentified species that you custom" package are adulterated in that they 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, 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:

1. 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 HACCP plans for:

a. air packaged, refrigerated, smoked trout to control the food safety hazard of pathogen growth, including Listeria monocytogenes;

b. air packaged, refrigerated, smoked salmon to control the food safety hazard of pathogen growth, including Listeria monocytogenes;

c. vacuum packaged, refrigerated, smoked trout to control the food safety hazards of pathogen growth and Clostridium botulinum toxin formation;

d. vacuum packaged, refrigerated, smoked salmon to control the food safety hazards of pathogen growth and Clostridium botulinum toxin formation;

e. refrigerated, raw trout packaged in sealed, plastic sleeves to control the food safety hazards of pathogen growth and Clostridium botulinum toxin formation; and

f. air packaged, refrigerated, smoked mixed fish of unidentified species to control the food safety hazards of potential histamine formation and of pathogen growth, including Listeria monocytogenes.

2. You must monitor sanitation conditions and practices during processing, with sufficient frequency to ensure, at a minimum, compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, sanitation deficiencies were observed in areas that should have been monitored by your firm, as specified below:

a. Your firm did not monitor for the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, as evidenced by the following:

• An employee removed racks of smoked fish from the smoker while wearing a plastic apron on which there were spots of wet fish blood. The employee leaned over smoked fish on a lower rack.

• An employee removing racks of smoked fish wore mittens that appeared soiled and came in close proximity to the smoked fish near the edge of the rack.

• Employees wore visibly soiled, personal clothing while processing raw fish, and were observed wearing the same clothing while packaging smoked fish products.

• Packaging materials for smoked fish were stored under a table where racks of raw fish drained onto the table top and dripped down near the packaging material.

b. Your firm did not monitor for the protection of food, food packaging material, and food contact surfaces from adulteration with cleaning compounds, sanitizing agents and other physical contaminants, as evidenced by the following:

• An employee was observed mixing bleach with detergent, which is not the appropriate method to apply a sanitizer. In addition, the employee did not measure to ensure that the correct amount of bleach was used to make a sanitizing solution.

• The smoker was not cleaned to remove accumulated creosote residues. An employee was observed removing what appeared to be creosote residues from the exterior of the finished smoked fish.

c. Your firm failed to maintain hand washing arid hand sanitizing facilities, as evidenced by the following:

• After washing hands during fish cleaning, fish smoking, and fish packaging operations, employees wiped hands with cloth towels that had been used to wipe equipment.

• Hand sanitizer was not used before bate hand contact with smoked fish during packaging.

d. Your firm did not monitor the safety of water that comes into contact with food or food contact surfaces, as evidenced by the following:

• There were no backflow prevention devices on the hose connections in the fish cleaning area, and in the sanitizer/ detergent storage area.

In addition, the following labeling violation was observed:

Your smoked fish products with added flavors are misbranded within the meaning of section 403{i){2) of the Act [21 U.S.C. § 343{i){2)] in that they are fabricated from two or more ingredients, but the labels fail to declare the common or usual name of each ingredient in the product as required by 21 CFR 101.4. Specifically, the ingredient statements fail to contain the added seasoning ingredients used on your brown sugar, Cajun, and garlic peppercorn-flavored products.

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.

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.

This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood establishment operates.in compliance with the Act, the seafood HACCP regulation (21 CFR 123), the Current Good Manufacturing Practice regulation (21 CFR 110), and the Food Labeling Regulations (21 CFR 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for your fish or fishery products.

Please send your written reply to Dr. Brian D. Garthwaite, Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter please contact Dr. Garthwaite at (612) 758-7132.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District

xc: Nathan Wendt
Operations Manager
Rainbow Springs, LLC dba Star Prairie Trout Farm
400 Hill Avenue
Star Prairie, WI 54026

Jeffry A. Taylor
General Manager, Rainbow Springs, LLC dba Star Prairie Trout Farm
Dungarvin Minnesota, LLC
690 S. Cleveland Avenue
St. Paul, MN 55116