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Country Maid, Inc. ***** 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) ***** FAX: (612) ***** November 8, 2011 WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED Refer to MIN 12 - 03 William W. Carr President Country Maid, Inc. 1919 S. Kinnickinnic Avenue Milwaukee, Wisconsin 53204 Dear Mr. Carr: We inspected your seafood processing facility located at 1919 S. Kinnickinnic Avenue, Milwaukee, Wisconsin, on July 8 to July 20, 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 (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 Seafood Supreme, Tuna Salad, Tuna Penne Salad, Seafood Delight, Shrimp Pasta Salad, Crab and Shrimp Salad, and Seafood 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 on FDA’s home page at www.fda.gov. Your most significant violations were 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 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 plan for “Fully Cooked Not Heat Treated Not Shelf Stable Ready to Eat Tuna Salads” does not list the food safety hazard of Clostridium botulinum for finished product that is packaged in containers of 5 pounds or more in weight. 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, your firm’s HACCP plan for “Fully Cooked, Not Heat Treated Not Shelf Stable Ready to Eat Surimi Salads, Spreads and Dips” lists a critical limit of (b)(4), at the (b)(4) critical control point that is not adequate to control Clostridium botulinum when the finished product is packaged in containers of 5 pounds or more in weight. 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 “Fully Cooked Not Heat Treated Not Shelf Stable Ready to Eat Shrimp Salads, Spreads, and Dips” does not list the monitoring procedure(s)/frequency at the Weight/Package Finished Product critical control point to control Clostridium botulinum. We note that your letter of August 5, 2011, states that the control of Clostridium botulinum for the above listed products will be through the standardization of formulation to ensure a pH of no greater than (b)(4). However, this change was not made on all plans as noted in the above citations. Additionally, the plan which was changed does not reflect a procedure or frequency for ensuring such formulation was met and no verification step is identified to ensure that the finished product pH, taken at equilibrium, is no greater than (b)(4). As for the remainder of the items addressed in your letter, we will review the efficacy of the implementation of these corrections during a subsequent inspection. This letter may not list all the violations at your facility. You are responsible for ensuring your firm operates in compliance with the Act and FDA’s implementing regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice. Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining violations will be corrected. Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address on this letterhead. If you have questions regarding the issues in this letter, please contact Ms. Wisecup at (612) ***** Sincerely, /S/ Gerald J. Berg Director Minneapolis District