Inspections, Compliance, Enforcement, and Criminal Investigations
Hearn-Kirkwood Incorporated 5/7/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5703
CMS # 52282
May 7, 2009
RETURN RECEIPT REQUESTED
Mr. Charles J. Gilbert, President
7251 Standard Drive
Hanover, MD 21076-1322
Dear Mr. Gilbert:
We inspected your seafood processing facility, located at 7251 Standard Drive, Hanover, MD 21076 on January 13 through January 23, 2009. 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 and tuna salads 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, after review of your product labels, we found your seafood and tuna salad products to be misbranded under section 403 of the Act [21 U.S.C. § 343]. You may find the Act, the seafood HACCP regulation, the food labeling regulation, and the Fish and Fisheries Products Hazards & Controls Guidance: 3rd Edition (the Hazard Guide), through links in FDA's home page at www.fda.gov.
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 has not conducted a hazard analysis for your seafood and tuna salad products and does not have a HACCP plan for the seafood and tuna salads to control for the food safety hazards of pathogen growth, toxins, and allergens.
Once you have conducted a hazard analysis for your seafood and tuna salad products, 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.
Your seafood salad product in 8 oz and 10 pound containers is misbranded within the meaning of section 403(i)(2) of the Act (21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2). The formulation sheet for this product indicates that the product contains several ingredients that are not declared on the labels: scallions, lemon juice, white pepper, old bay, and pickle relish. Additionally, according to your formulation sheet, your seafood salad product contains the ingredient imitation crabmeat (b)(4), which, according to the imitation crabmeat label, is comprised of several sub-ingredients that are not declared on the label: fish proteins of Pollock, Whiting, Cod and/or Threadfin Bream, water, wheat, com or tapioca starch, egg whites, natural crab flavor, natural crab extract, sugar, rice wine, salt, calcium carbonate, titanium di-oxide, carmine, and paprika.
Your tuna salad product in 8 oz and 10 pound containers is also misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2). Specifically, the formulation sheet for this product lists tuna as an ingredient, which, according to the label of the tuna, contains the following sub-ingredients that are not identified on the tuna salad labels: salt, vegetable broth, and sodium acid pyrophosphate. The tuna ingredient also contains water, which is declared on the label only as a sub-ingredient of the mayonnaise ingredient; therefore, it must be declared as a sub-ingredient of the tuna or declared as an ingredient of the tuna salad product, as described below. In addition, the formulation sheet collected during the inspection showed that relish and black pepper are ingredients in the tuna salad; however, relish and black pepper are not listed in the ingredient statement.
The requirement to list these 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 [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 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.
Your seafood salad product in 8 oz and 10 pound containers is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] because the labels fail to list the food allergens fish, wheat, and soy. Section 201(qq) of the Act [21 U.S.C.§ 321(qq)] defines as "major food allergens" fish, wheat, eggs, Crustacean shellfish, tree nuts, peanuts, milk, 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:
i. 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)(l)(A) of the Act, 21 U.S.C. § 343(w)(l)(A)], or
ii. 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, 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)(l)(B) of the Act, 21 U.S.C. 343(w)(l)(B)].
As discussed above, the labeling our investigators collected for your seafood salad declares imitation crabmeat as an ingredient but does not declare the sub-ingredients contained within the imitation crabmeat. According to its label, the imitation crabmeat contains the major allergens eggs, soy, fish, and wheat; however, only the eggs are identified on the labels of your seafood salad product. For fish and Crustacean shellfish, the term "name of the food source from which the major allergen is derived" means the species of fish or Crustacean shellfish [section 403(w)(2) of the Act, 21 U.S.C. 343(w)(2)]. If the crab flavor or crab extract contains crab protein, crab must also be identified as an allergen on the label.
Your seafood and tuna salad products in 8 oz and 10 lb containers are misbranded under section 403(e) of the act because the labels fail to bear the place of business of the manufacturer. In addition to the location of the business, the label must state the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation [21 CFR 101.5(b)]. The labels for the 8 oz seafood and tuna salad products show "Food Unlimited" as the name of the manufacturer. According to information obtained by the investigator during the inspection, Food Unlimited is a subsidiary of Hearn-Kirkwood Inc. and not the actual corporate name.
Your seafood and tuna salad products in 8 oz and 10 pound containers are misbranded under 403(q) of the Act in that there is no nutrition labeling on their labels, as required by 21 CPR 101.9(a). Nutrition information must be provided for all food products intended for human consumption and offered for sale unless an exemption is provided for the product. Your seafood salad and tuna salad are not subject to an exemption from nutrition labeling requirements [21 CPR 101.9(j)].
In addition to the above violations, we also have several observations regarding your labeling. First, we note that the labels for the 8 oz tuna and seafood salads are difficult to read because of the small type size and the particular font used for the ingredient statements. When the labels are reprinted, we recommend that you make the labels more legible and to use type that is at least 1/16 inches in height as measured by the lower case "e."
Several of your product labels declare ingredients that are not listed on the product formulation sheets collected by our investigator. Specifically:
• The labels on the 8 oz and 10 pound containers of your Tuna and Seafood Salads declare "red onion" as an ingredient, but the formulation sheet for these products does not list this ingredient.
• The labels on the 8 oz and 10 pound containers of your Seafood Salad declare that the product contains red and yellow peppers, but the formulation sheet for this product does not list these ingredients.
• The label on the 10 pound container of your Seafood Salad declares "salt" as an ingredient, but the formulation sheet for this product does not list this ingredient.
You should ensure that your product labels declare only those ingredients contained in the products. If you continue to manufacture your tuna and seafood salad products according to the product formulations provided to our investigator, you should ensure that their labels list only those ingredients specified on these formulation sheets.
This letter may not list all the violations at your facility. Other violations can subject the food to legal action. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood RACCP regulation (21 CFR Part 123), 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.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)) and the seafood HAACP regulation.
You should respond in writing within fifteen (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 U.S. Food and Drug Administration, Attention: Anne Aberdeen, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Aberdeen at (410) 779-5134.