| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human ServicesMay 12, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 26
Terry L. Swan
Co-owner and Vice President
Dawn's Foods, Inc.
1530 La Dawn Drive
Portage, Wisconsin 53901
Dear Mr. Swan:
We inspected your seafood processing facility located at 1530 La Dawn Drive, Portage, Wisconsin, on February 14-22,2011. 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 Alaskan Krab Salad, Deluxe Seafood Salad, Tuna Macaroni Salad, Tuna Salad, Cajun Krab Dip, 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. In addition, you may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links on FDA's home page at www.fda.gov.
Your significant violations were 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plans for Alaskan Krab Salad, Seafood Salad, Cajun Krab Dip, Smoked Salmon Dip, and Tuna Salad and Tuna Macaroni Salad do not list the food safety hazard of Clostridium botulinum growth and toxin formation at the (b)(4) '" and (b)(4)" critical control points. We acknowledge that your plans identify "(b)(4)." However, because these products are packaged in large, deep containers (i.e., 5 lb) the finished packaged products pose a risk specifically associated with Clostridium botulinum toxin formation. Consequently, we recommend that in addition to refrigeration of the products, your firm adopt a secondary control strategy to prevent toxin formation. For example, you may include formulations of the products to ensure that the pH is controlled at 5.0 or below, or that the water phase salt is controlled at 5% or more, or that the water activity is controlled at 0.97 or below. Alternatively your firm may choose to maintain the finished products at or below 38°F and use a time/temperature indicator (TTI) on each package.
2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However,
A. Your firm's HACCP plan for Alaskan Krab Salad, Seafood Salad, and Cajun Krab Dip lists a critical limit (b)(4) at the (b)(4) critical control point, and a critical limit (b)(4) at the (b)(4) critical control point that are not adequate to control Clostridium botulinum growth and toxin formation, and also a critical limit (b)(4) at the (b)(4) critical control point that is not adequate to control pathogen growth.
B. Your firm's HACCP plan for Smoked Salmon Dip lists a critical limit (b)(4) at the (b)(4) critical control point that is not adequate to control Clostridium botulinum growth and toxin formation, and a critical limit (b)(4) at the "(b)(4)" critical control point that are not adequate to control pathogen growth.
C. Your firm's HACCP plan for Dawn's Tuna Salad and Tuna Macaroni Salad lists a critical limit (b)(4) at the (b)(4) critical control points that is not adequate to control pathogen growth and histamine formation. In addition, this plan lists a critical limit (b)(4) at the (b)(4) critical control point that is not adequate to control pathogen growth and histamine formation.
3. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the (b)(4) critical control point to control allergens listed in your HACCP plan for Tuna Salad and Tuna Macaroni Salad, and in your HACCP plan for Smoked Salmon Dip.
A. The processing and critical control point monitoring records dated 01/27/2011 document your manufacture of Tuna Macaroni Salad. A process Control Log was not completed for that product on that day.
B. On 01/31/2011 you manufactured Smoked Salmon Dip. A process Control Log was not completed for that product on that day.
4. Since you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for Alaskan Krab Salad, Seafood Salad, Cajun Krab Dip, Smoked Salmon Dip, and Tuna Salad and Tuna Macaroni Salad at the "(b)(4) critical control points are not adequate to control (b)(4)" Your firm should list that you will segregate and re-label any improperly labeled product, and modify your labeling procedures as appropriate to regain control of the operation.
5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current Good Manufacturing Practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, with sufficient frequency to ensure compliance with the current Good Manufacturing Practice requirements in 21 CFR Part 110 as evidenced by: on 02/14/2011 a water hose that did not contain backflow prevention was submerged inside a pasta cooker that contained elbow pasta for Deluxe Seafood Salad. Also, during the inspection, the backflow prevention devices that were installed on hoses subjected to constant pressure were single check valves located prior to the hose nozzle shut off. This method of installation does not ensure backflow siphoning prevention.
Please note that FDA has recently published a 4th edition of the "Fish and Fisheries Products Hazards and Controls Guidance." This new publication provides the most current information to assist processors in developing their HACCP plans. For specific information related to the hazard of "Undeclared Major Food Allergens... " please refer to Chapter 19. For additional information on the hazard of Clostridium botulinum toxin formation, please refer to Chapter 13.
We may take further action if you do not promptly correct these violations. 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 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 the letterhead. If you have
questions regarding any issues in this letter, please contact Ms. Caulfield at (612) 758-7194.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
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