Inspections, Compliance, Enforcement, and Criminal Investigations
Bruno's of Duluth, Inc. 06-Aug-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
August 6, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 08-06
Katerina J. Anderson
Bruno's of Duluth, Inc.
P.O. Box 16134
Duluth, Minnesota 55811
Dear Ms. Anderson:
We inspected your seafood processing facility, located at 4451 Airpark Boulevard, Duluth, Minnesota, on February 27-29, 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, 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 New England Clam Chowder is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
In addition, five of your Bruno's brand of soups, two flavor bases distributed under our Old World Recipe brand label; and your private-label soups prepared for [redacted] and [redacted] are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare milk and/or egg, which are major food allergens present in your products. You may find the Act, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance, and the labeling regulations through links in FDA's home page at www.fda.gov.
Your most significant HACCP 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 a HACCP plan for New England Clam Chowder to control the food safety hazards of pathogen growth and toxin formation.
Your hazard analysis should evaluate the hazards of pathogen growth and toxin formation and pathogen survival through cooking. Once you have conducted a hazard analysis for your clam chowder product, your HACCP plan must, at a minimum, list hazards that are reasonably likely to occur and include appropriate critical control points, critical limits, monitoring procedures, any corrective action plans you have developed to address deviations from critical limits, verification procedures, and recordkeeping activities to ensure that the food safety hazards are controlled.
We acknowledge that during the inspection, you submitted a document entitled "HACCP Plan For Production of Bruno's Boil-in-a-Bag Clam Chowder." However, this document is a recipe for your product and does not include any of the necessary components of a HACCP plan.
2. 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 monitoring records for: (1) safety of water that comes into contact with food or food contact surfaces, including water used !to manufacture ice; (2) condition and cleanliness of food contact surfaces; (3) prevention of cross-contamination from insanitary objects; (4) maintenance of hand washing, hand sanitizing, and toilet facilities; (5) protection of food, food packaging material, and food contact surfaces from adulteration; (6) proper labeling, storage, and use of toxic chemicals; (7) control of employee health conditions; and (8) exclusion of pests, as required for the processing of your New England Clam Chowder.
During the inspection, copies of your product labels were collected. Review of these labels revealed that several of your firm's products are misbranded within the meaning of section 403 of the Act.
Your Bruno's Minnesota Wild Rice Soup, Old Fashion Dumpling Soup, Noodle Soup, Split Pea Soup, and Bean Soup, the [redacted] Chicken and Ham Flavor Bases distributed under your Old World Recipe brand label, and your private-label products [redacted] Old Fashion Dumpling Soup, [redacted] Cream of Wild Rice Soup, and [redacted] Cream of Rice Soup are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare milk, a major food allergen present in your products, as required by section 403(w)(1). These soup products contain either the Chicken Flavor Base or the Ham Flavor Base, which contain the sub-ingredients whey protein and dry whey, respectively. The labels for the Bruno's soup and flavor base products declare the presence of whey protein or dry whey; however, these labels, as well as those for your private-label soup products, fail to identify the major food allergen milk.
Your private-label product [redacted] Old Fashion Dumpling Soup is also misbranded within the meaning of section 403(w) of the Act in that the label fails to declare the presence of the, major food allergens wheat and egg, as required by section 403(w)(1) of the Act. Specifically, your Old Fashion Dumpling Soup product is manufactured using wheat flour and dried eggs. However, the label on this product fails to declare the presence of the allergenic ingredients wheat and egg.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines as major food allergens milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
• The word "Contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients (section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]), or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen, is derived [e.g., "whey (milk)"], except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) (section 403,(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)]).
Additionally, your private-label products [redacted] Old Fashion Dumpling Soup, [redacted] Cream of Wild Rice Soup, and [redacted] Cream of Wild Rice Soup are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients, but the labels fail to list all sub-ingredients (ingredients of an ingredient in the finished product) As discussed above; these products contain the ingredient chicken base, which is composed of several sub-ingredients (e.g., chicken and whey protein) that are not declared on the product labels as required by 21 CFR 101.4(b)(2). The Old Fashion Dumpling Soup label has an ingredient statement that also lists "egg dumpling," which is composed of several sub-ingredients (e.g., eggs and flour) that are not declared on the label.
The requirement to list sub-ingredients in the ingredient statement of the finished food may be met either by parenthetically listing the sub-ingredients after the common or usual name of the multi-component ingredient of which they are a part, or by listing the sub-ingredients without listing the multi-component ingredient itself. Under the first alternative, the sub-ingredients must be listed in descending order of predominance within the multi-component ingredient, and under the second alternative, the sub-ingredients must be listed in descending order of predominance in the finished food [21 CFR 101.4(b)(2)].
We may take further action if you do not promptly correct these violations. For instance, we may seize your product 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, revised product labels, 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.
In addition, we have the following comments regarding your product labels:
1. We note that your firm advised the District that you corrected your labels to include the declaration of FD&C Yellow #5 and #6 for the following products: Bruno's Noodle Soup and Bruno's Old Fashion Dumpling Soup. Your firm corrected these labels with a sticker near the ingredient statement that reads "CONTAINS FD&C YELLOW 5 & 6." In your response to this Warning Letter, you should identify the date by which your firm will begin to use revised labels that incorporate the color ingredients as part of the ingredient statement.
2. The Nutrition Facts information on the labels of the Minnesota Wild Rice Soup, Old Fashion Dumpling Soup, Noodle Soup, Split Pea Soup, and Bean Soup is not set off in a box by itself by the use of hairlines, as required by 21 CFR 101.9(d)(1)(i).
3. The 18-ounce packages of the Minnesota Wild Rice Soup, Old Fashion Dumpling Soup, and Noodle Soup declare "Servings Per Container: 2.25." In accordance with the requirements of 21 CFR 101.9(b)(8)(i), the number of servings between 2 and 5 must be rounded to the nearest 0.5 serving.
4. You distribute Bruno's Chicken Flavor Base, Ham Flavor Base, and Beef Flavor Base under your Old World Recipe label. During the inspection the investigator found that the manufacturer is [redacted] The labels for the Old World Recipe Chicken Flavor Base, Ham Flavor Base, and Beef Flavor Base do not qualify the name and address of the responsible firm with a statement such as "distributed by" in accordance with 21 CFR 101.5(c).
5. As discussed above your [redacted] Old Fashion Dumpling Soup, [redacted] Cream of Wild Rice Soup, and [redacted] Cream of Wild Rice Soup private-label products have labels that fail to declare all sub-ingredients, as required under section 403(i)(2) of the Act, and also fail to declare the presence of allergens, as required under section 403(w) of the Act. Your distributors should also ensure that any labels they may provide for these products declare the presence of all sub-ingredients and allergens.
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 labeling regulation (21 CFR 101), 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.
Your response should be sent to Jane Nelson, Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter please contact Ms. Nelson at (612) 758-7119.
W. Charles Becoat