Inspections, Compliance, Enforcement, and Criminal Investigations
Karlsburger Foods, Inc. 12/16/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7194
FAX: (612) 334-4142
December 16, 2010
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 08
Michael M. Maher
President/Chief Executive Officer
Karlsburger Foods, Inc.
3236 Chelsea Road West
Monticello, Minnesota 55362
Dear Mr. Maher:
We inspected your seafood processing facility located at 3236 Chelsea Road West, Monticello, Minnesota, on June 21-25, 29 and July 19, 2010. 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 Soup Bases (Shrimp, Lobster, Clam, Seafood, and Crab) 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, our review of your product labels reveals that your Hollandaise Classic Sauce Mix, Chicken Flavor Base, and Clam Base products are in violation of the Act in that your products are misbranded within the meaning of section 403(i) of the Act, 21 U.S.C. § 343(i), and the regulations in 21 CFR 101. 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
• three HACCP plans for Soup Bases Fish, shrimp/lobster, and clams/shellfish do not list the food safety hazard of Metal; and
• the HACCP plan for Soup Base Fish does not list the food safety hazard of Allergens and/or allergenic ingredients.
2. 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 plans for Soup Bases Fish, shrimp/lobster, and clams/shellfish do not list the two critical control points of
• thawing for controlling the food safety hazard of pathogens, specifically Clostridium botulinum growth and toxin formation, because the products are received and defrosted in vacuum-packaged bags; and
• cooling for controlling the food safety hazard of pathogen growth after cooking.
During the inspection, labels of your products were collected for review. We have reviewed your product labels and have determined that your Karlsburger Hollandaise Classic Sauce Mix and Chicken Flavor Base products 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 labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight. Specifically, both products list flour and (b)(4) on the formulation sheets but fail to list all of the sub-ingredients of the flour and (b)(4) on your products’ finished labels, as required by 21 CFR 101.4(b)(2).
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
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.
We note that your Chicken Flavor Base product formulation sheet states “Light Sodium” and your product label states that it is “LS,” which intends to claim that the product is light in sodium; however, the claim does not meet the requirements to make a “light” claim, 21 CFR 101.56(c).
Section 403(w)(2) of the Act, 21 U.S.C. § 343(w)(2), states that the term “name of the food source from which the major food allergen is derived” for fish or Crustacean shellfish means the specific type of fish or Crustacean shellfish. Your Crab Flavor Base product, labeled under the Karlsburger brand, has a “Contains” statement that lists the specific Crustacean shellfish as Crab; however, for the fish ingredient, the Contains statement only lists fish and does not identify the specific species as required.
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 and all applicable regulations, including the seafood HACCP regulation (21 CFR 123), the Current Good Manufacturing Practice regulation (21 CFR 110), and the Food Labeling regulation (21 CFR 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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.
Please send your reply to the Food and Drug Administration, Attention: Compliance Officer Rebecca L. Caulfield, at the address indicated on the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612)758-7194.
Gerald J. Berg