Inspections, Compliance, Enforcement, and Criminal Investigations
Smith Family Frosted Foods LLC 5/21/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
May 21, 2012
WARNING LETTER CIN-12-283044-18
Aaron F. Smith, President
Smith Family Frosted Foods, LLC
1773 West County Road 54
Tiffin, OH 44883
Dear Mr. Smith:
We inspected your seafood processing facility located at 1773 W. Country Road 54, Tiffin Ohio on January 24, 25, 27, 31 and February 1, 2012. 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)]. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in the FDA’s home page at www.fda.gov.
In addition, a copy of the label for your Granny Smiths Kitchen brand Seafood Pasta Salad in 5lb. tubs, was collected and the label for your Breaded Yellow Lake Perch in 10lb. boxes and House of Meats brand Shell Macaroni Salad were photographed. We have reviewed your labels and find that you have serious violations of the Color Additive and Food Labeling Regulations, Title 21, Code of Federal Regulations, Part 74 and 101 (21 CFR 74 and 101). Consequently, your House of Meats brand Shell Macaroni Salad is adulterated within the meaning of section 402(c) and misbranded within the meaning of section 403(i)(2) and 403(k) of the Act; your Breaded Yellow Lake Perch is also misbranded within the meaning of 403(i)(2). You may find the Act, the Color Additive regulation and the Labeling regulation through links on the FDA’s home page at www.fda.gov.
Your significant violations were as follows:
Seafood HACCP Violations:
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 HACCP plans for the manufacturing of:
a. Frozen breaded raw yellow lake perch fillets to control the hazards of Staphylococcus aureus toxin formation, food allergens, and metal inclusion. We acknowledge your response regarding Staphylococcus aureus where you note that your firm maintains the processing room at 45° F, therefore extending the time for safely completing the processing operation. However, because your firm is relying on temperature controls to ensure the safety of the product during processing, your firm will need to include processing as a critical control point and include the critical limits for ambient temperature of the room coupled with the time period. Please refer to Chapter 15 of the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (i.e., the Hazards Guide) for additional information related to breaded and battered products.
b. Refrigerated ready-to-eat (RTE) seafood salads in 5 lb. plastic tubs to control the hazards of Clostridium botulinum toxin formation. Large and/or deep containers create conditions conducive to Clostridium botulinum growth and potential toxin formation. Consequently, refrigerated fish and fishery products that are packaged in large and/or deep containers need to address this hazard by implementing a secondary barrier, in addition to refrigeration, to reduce the likelihood for toxin formation. For additional information related to these types of refrigerated products, please refer to Chapter 13 of the 4th Edition of the Hazards Guide.
In addition, we recommend refrigerated storage for controlling the food safety hazard of pathogen growth and potential toxin formation, including Clostridium botulinum growth and toxin formation during thawing, as well as during finished product storage. Pathogen growth and potential toxin formation, including toxin formation from Clostridium botulinum are reasonably likely hazards associated with these operations. FDA further suggests the use of a continuous monitoring and recording device such as a continuous temperature data logger for monitoring refrigerated storage temperatures on each of your refrigerators. We also recommend a daily check of the recorded temperatures to ensure that your critical temperature limits have not been exceeded. We also recommend a daily check of the monitoring equipment itself to ensure that it is operating properly. For more information on the hazard of Clostridium botulinum growth and toxin formation, please refer to Chapter 13 of the 4th Edition of the Hazards Guide.
We acknowledge your undated corrective action letter, which we received on 2/28/2012. However, this letter is inadequate because it did not include a HACCP plan for your products. Your firm must have and implement a HACCP plan that addresses the above listed hazards.
2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice (cGMP) requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor protection of food, food packaging material, and food contact surfaces from adulteration with sufficient frequency to ensure compliance with the cGMP requirements in 21 CFR Part 110 as evidenced by:
a. An employee touched a power strip and cord with dark brown residue and then touched ready-to-eat crabmeat without changing or washing/sanitizing their disposable gloves.
b. An employee placed pieces of ready-to-eat imitation crabmeat on top of the pouch in which it was packaged before adding it to the batch.
c. An employee used a squeegee that was in contact with black residue on the wall to remove excess water from a production table. Utensils and other production equipment were then placed on the production table.
d. An employee used a spray bottle that did not have the contents identified to sanitize the stainless steel processing table and production utensils. An employee told our investigator that the solution was quaternary ammonium sanitizer, but testing by the FDA did not show the presence of any concentration of sanitizer.
e. You reported that you do not monitor employee health conditions prior to allowing them to prepare the frozen breaded raw yellow lake perch fillets and the refrigerated ready-to-eat seafood salads. Further your sanitation monitoring records do not indicate that you monitor for employee health conditions, toilet facilities and exclusion of pests.
Your response to this observation is not adequate. You have not provided any evidence to show that these issues have been corrected. For example, you have not provided any employee re-training records or documentation showing the monitoring of employee health conditions, toilet facilities or exclusion of pests.
- Your House of Meats brand Shell Macaroni Salad (5 lb. tub) is adulterated within the meaning of section 402(c) of the Act because the product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379e(a)]. Section 721(a) deems a color additive to be unsafe if its use is not in conformity with the color additive listing regulation. Your House of Meats brand Shell Macaroni Salad (5 lb. tub) is manufactured with (b)(4) brand Yellow Color, which contains FD&C Yellow No. 5. Pursuant to 21 CFR 74.705(d)(2), FD&C Yellow No. 5 must be declared by that name as an ingredient when used in the manufacture of a food product. However, the label for House of Meats brand Shell Macaroni Salad fails to declare the presence of FD&C Yellow No. 5 in the ingredient statement.
- Your House of Meats brand Shell Macaroni Salad (5 lb. tub) is misbranded within the meaning of Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product bears or contains artificial coloring but does not bear labeling stating that fact. In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. Under 21 CFR 101.22(k)(1), certified colors must be declared by the name of the color additive listed in the applicable regulation. The common or usual name may be abbreviated to omit the “FD&C” prefix and the term “No.” (e.g., Yellow 5). Your products do not meet this requirement. Specifically:
- Your House of Meats brand Shell Macaroni Salad (5 lb. tub) statement of ingredients lists “Yellow Food Coloring.” The yellow food coloring in the product formulation refers to (b)(4) brand Yellow Color, which contains FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40. However, these color additives are not declared in the product’s statement of ingredients.
- Your House of Meats brand Shell Macaroni Salad (5 lb. tub) is misbranded within the meaning of section 403(i)(2) of the Act because it contains color additives subject to certification that are not declared in the ingredient statement as required by 21 CFR 101.22(k)(1). Your formulation includes the presence of (b)(4) brand Yellow Color which includes FD&C Yellow No. 5, FD&C Yellow No. 6 and FD&C Red No. 40. These certified colors must be individually declared by the appropriate common or usual name: FD&C Yellow No. 5, FD&C Yellow No. 6 and FD&C Red No. 40 (these names may be abbreviated by omitting the term “FD&C” or the term “No.,” e.g. Yellow 5, Yellow 6 and Red 40) in the ingredient statement. We acknowledge that you have recalled this product.
- Your Breaded Yellow Lake Perch in 10 lb. boxes is further misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that your label fails to declare all of the ingredients used by your firm in the production of this breaded fish in accordance with 21 CFR 101.4(a)(1). Specifically, your statement of identity states “Breaded Yellow Lake Perch”, however Perch is not one of the ingredients listed in the ingredient statement.
- Your Granny Smith’s Kitchen Seafood Pasta Salad is also misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the label fails to declare the common or usual name of every component in the imitation crabmeat in descending order of predominance with all of the other ingredients contained in the finished food in accordance with 21 CFR 101.4(b)(2)(ii). Every component for the imitation crabmeat is declared at the beginning of the ingredient statement of the finished food, including a “contains 2 % or less of the following” statement which makes it appear that all of the other ingredients following that statement used to formulate your pasta salad are present at less than 2%.
- Your House of Meats brand Shell Macaroni Salad (5 lb. tub) and Granny Smiths Kitchen brand Seafood Pasta Salad (5lb. tub) products are further misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the ingredient statement declares the presence of the chemical preservative potassium sorbate, but fails to provide a separate description of the function of the ingredient as required. In accordance with 21 CFR 101.22(j), the label of a food to which a chemical preservative has been added shall bear a label declaration stating both the common or usual name of the ingredient and a separate description of its function, e.g. “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. We also note that if the sodium benzoate is used as a preservative, its function must be declared.
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 seafood HACCP regulation (21 CFR Part 123) and that your products are labeled in accordance with the labeling regulations (21 CFR Part 101) and color additive regulations 921 CFR Part 74). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
In addition to the above violations, we also share the following labeling comments:
- Your House of Meats brand Shell Macaroni Salad (5 lb. tub) product declares “Macaroni” which in accordance with the standard at 21 CFR 139.115 includes semolina, durum flour, niacin, iron (ferros [sic] sulfate), thiamin mononitrate, riboflavin, and folic acid. It appears your House of Meats brand Shell Macaroni Salad contains enriched macaroni, but you fail to list it as such on the ingredient statement of your product.
- The statement “Perishable Keep Refrigerated” is intervening material between the ingredient statement and allergen "Contains" statement on your House of Meats brand Shell Macaroni Salad (5 lb. tub) and Granny Smiths Kitchen brand Seafood Pasta Salad (5lb. tub) product labels [403(w)(1)(A)].
- The statement “Cooking Instructions…” is intervening material between the ingredient statement and allergen "Contains" statement on your Breaded Yellow Lake Perch in 10lb. boxes product label [403(w)(1)(A)].
- Your Granny Smiths Kitchen brand Seafood Pasta Salad finished product label includes a “Contains” statement which does not properly declare the major food allergen, Pollock, cod and/or whiting, in the product [403(w)(2)]. Even though your ingredient statement lists “Pollock, cod and/or whiting” as part of the sub-ingredients for the fish protein in your product, you have also elected to include a “Contains” statement which fails to declare the name of the food source from which the major food allergen is derived from, e.g. Pollock, cod and/or whiting. Also, your Breaded Yellow Lake Perch in 10lb. boxes provides a “Contains” statement, but does not declare the name of the food source from which the major food allergen is derived (species of fish), Yellow Perch.
- Your House of Meats brand Shell Macaroni Salad (5 lb. tub) product label contains false or misleading statements [21 CFR 101.18]. Specifically, your product label includes “onion powder” in the ingredient statement; however the formulation for your product reveals that onion powder is not used in the manufacture of this product.
- The Breaded Yellow Lake Perch ingredient label includes the statements “spice (including celery)” and “Dipped in…” Such statements are not provided for in 21 CFR 101.4.
- The ingredient list for the Breaded Yellow Lake Perch declares the ingredient “Bleached Wheat Flour” twice but in neither case is it declared as a sub-ingredient of another ingredient. If the intent was to declare the ingredients in accordance with 101.4(b)(2)(ii), “Bleached Wheat Flour” would not need to be declared twice but the two amounts would be combined and placed in the appropriate order of predominance.
- The ingredient list for the House of Meats Shell Macaroni Salad (5lb. tub) does not include a close parenthesis “)” to indicate the end of the sub ingredients of the “salad dressing” ingredient.
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 re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance 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 foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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, 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.
Please send your reply to the Food and Drug Administration, Attention Stephen J. Rabe Compliance Officer, 6751 Steger Drive, Cincinnati, OH 45237. If you have questions regarding any issues in this letter, please contact Mr. Rabe at 513-679-2700 extension 2163.
Paul J. Teitell
Cc: Alex F. Smith, COO
Smith Family Frosted Foods, LLC
1773 West Country Road 54
Tiffin, OH 44883