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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) 334-4100
FAX: (612) 334-4142
April 9, 2014
Via UPS Overnight Delivery
Refer to MIN 14 – 16
Thomas J. Russell
President and CEO
Cloverdale Foods, Inc.
3015 34th Street NW
Mandan, North Dakota 58554
Dear Mr. Russell:
We inspected your seafood processing and sauce manufacturing facility, Boyko Foods, LLC, located at 212 Ball Park Street, Stanton, North Dakota, on December 10, 2013. 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 (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 Golden Breaded Shrimp Patties are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Additionally, your Don Diego brand South American Sauce and your Golden Breaded Shrimp Patties are misbranded within the meaning of section 403 of the Act, 21 U.S.C. § 343, and the applicable regulations in 21 CFR 101. You may find the Act, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance and the Food Labeling regulations through links on FDA’s home page at www.fda.gov.
Adulteration of product
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 Shrimp Patties to control the food safety hazards of pathogen growth and toxin formation, control of allergens, control of food additives, and detection of metals.
We acknowledge that you have documents identified for the monitoring of time/temperature for the batter used in production of your Shrimp Patties. However, the record is not always reviewed within the seven day requirement nor is the change in the critical limit signed and dated to show when the change was approved. We further acknowledge that you reference a HACCP plan in various records. However, the documents provided do not include the minimal information required to constitute a HACCP plan as required by 21 CFR 123.
Misbranding of products
1. Your Don Diego brand South American Sauce and your Golden Breaded Shrimp Patties 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 all major food allergens present in the products, as required by section 403(w)(1) of the Act.
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 certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded under section 403(w) of the Act 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., “flour (wheat)”, 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 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).
Specifically, your Don Diego brand South American Sauce and your Golden Breaded Shrimp Patties are manufactured using soybean; however, your labels fail to declare the major food allergen soybean.
2. Your Don Diego brand South American Sauce in bulk service containers is misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), because the label fails to declare any ingredients (see also 21 CFR 101.4).
3. Your Don Diego brand South American Sauce in retail size containers and Golden Breaded Shrimp Patties 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 as well as all sub-ingredients, as required by 21 CFR 101.4.
- Your Don Diego brand South American Sauce retail label declares Water, Distilled Vinegar, Soy Sauce, Tomato Paste, Salt, and Seasonings as ingredients. However, the label fails to list the specific sub-ingredients of the Soy Sauce, a product known to contain multiple ingredients, as required by 21 CFR 101.4(b)(2).
In addition, “Seasonings” is not an appropriate common or usual name for an ingredient as declared on this label. FDA has not defined the term “seasoning.” Collective terms such as “spices” and “flavors” are provided for in 21 CFR 101.4(b)(1) and 101.22; however, there are no regulations that provide for the use of the term “seasoning” as a collective term. When the term “seasoning” is used in regulations, it describes the function of various optional ingredients rather than a specific ingredient; therefore, use of the term would only be appropriate if the actual ingredient or sub-ingredient was declared.
- Your Golden Breaded Shrimp Patties fail to declare ingredients in accordance with 21 CFR 101.4. For example:
o The Savory Shrimp Marinade ingredient declares the sub-ingredient onion powder; however, the Golden Breaded Shrimp Patties ingredient statement does not include onion powder.
o The ingredient list declares “Beef fibrin (Beef Fibrin is Fibrogen and Thrombin Plasma Protein).” Our investigator observed that these are individual ingredients “beef plasma thrombin” and “beef plasma fibrinogen” rather than an ingredient “beef fibrin.” The ingredients “beef plasma thrombin” and “beef plasma fibrinogen” must be declared individually by their common or usual names in descending order of predominance in the finished product ingredient declaration.
o Your Golden Breaded Shrimp ingredient label declares, in part, “fish extract.” The fish extract is listed in the parenthetical listing of the ingredients for the Savory Shrimp Marinade. However, based on our observation, the label for the Shrimp Marinade ingredient does not include fish. The finished product ingredient declaration must accurately reflect the ingredients in the products.
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 multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food, 21 CFR 101.4(b)(2).
4. Your Don Diego brand South American Sauce retail product is misbranded within the meaning of section 403(q) of the Act, 21 U.S.C. § 343(q), in that it lacks a nutrition label in accordance with 21 CFR 101.9(a). We note that the website for your parent company, Cloverdale Foods, www.cloverdalefoods.com, includes the nutrition information for this product; therefore, this product is not exempt from nutrition labeling. Furthermore, we note that trans fat is not properly declared in accordance with 21 CFR 101.9(c)(2)(ii) in the labeling on this website.
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.
We have the following comments about your product labels:
> Your Golden Breaded Shrimp Patties label includes the statement “Meta Bisulfites may be present.” There are no provisions for such a “may be present” statement. Sulfiting agents are chemical preservatives; therefore, if added, the function must be declared in accordance with 21 CFR 101.22(j). “Meta Bisulfites” is not recognized as an appropriate common or usual name for a sulfiting agent.
> Your Don Diego brand South American Sauce bulk and retail product labels declare that the products are distributed by the South American Sauce Company, Mandan, North Dakota 58554. However, there is no listing in a local telephone directory for such a company. A street listing for the company must be included on the label, as required by 21 CFR 101.4(d).
> Your Don Diego brand South American Sauce retail product label shows the ingredient statement and the net weight on the information panel to the left of the principal display panel. The net weight must be listed on the principal display panel in the bottom 30% of the label per 21 CFR 101.105(f). The ingredient statement must be either on the principle display panel or on the information panel as provided for in 21 CFR 101.2 with no intervening material, i.e., on the panel which is immediately contiguous and to the right of the principle display panel unless the panel is too small to accommodate the information or is otherwise unusable.
Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
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
Michael Dutcher, DVM