| Public Health Service Food and Drug Administration |
Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human Services
May 19, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED Refer to MIN 11 - 30
Steven D. McKeon
President
Family Fresh Pack, LLC
112 West Main Street
Belleville, Wisconsin 53508
Dear Mr. McKeon:
We inspected your seafood processing facility located at 112 West Main Street, Belleville, Wisconsin, on December 22-23, 30, 2010, and January 18-19, 2011. 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 (cGMP) 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 Lobster Bisque, Shrimp Scampi and Crab Creole are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. 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:
- 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 HACCP plan for Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads does not list the food safety hazards of allergens, Clostridium botulinum and food intolerance substances. FDA recommends that controls for allergens and food intolerances (i.e., sulfite sensitivity) be controlled through a review of the ingredients on the finished product labels to ensure that allergens and any substances that cause food intolerances are accurately documented on the labels. Additionally, your firm is packaging the products in containers that are oxygen impermeable and thus create conditions conducive to Clostridium botulinum growth and toxin formation.
- You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads lists a critical limit, temperature (b)(4), that is not adequate to control pathogens. The temperature ranges you have listed as critical limits for storage may result in your product being held at temperatures that support pathogen growth for extended periods of time. We recommend continuously maintaining storage temperatures at or below 38°F.
- You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at (b)(4) critical control point to control pathogens listed in your HACCP plan for Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads. Specifically, the following were observed:
- During the inspection noted above, you did not have monitoring records that document control of sulfites in your frozen shrimp product since the previous FDA inspection dated January 21, 2010. At that time, you did not have temperature recording charts for your seafood cooler from February 8 through November 15, 2010. However, you manufactured and stored seafood in this cooler on a regular basis during that time.
- You were storing Crab Creole cold pack cheese in Cooler #1. This cooler did not have a temperature recording device.
- On December 20, 2010, the temperature recording chart for the seafood cooler was blank because the pen was out of ink.
- You did not address the affected product that was stored in your seafood cooler and Cooler #1 when the coolers were not being monitored.
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with 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:
- Employees were observed placing their fingers inside filled cheese cups while moving them to the check weighing scale without first washing and sanitizing their hands.
- 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 the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing and sanitizing of toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions, and exclusion of pests required for the processing of Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads from January 21 – December 22, 2010.
- Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads at (b)(4) critical control point to control pathogens to include Clostridium botulinum is not appropriate. Specifically, the corrective action does not (b)(4).
Misbranded Seafood
Your Spreadable Shrimp Scampi is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that it fails to declare all major food allergens present in the product, as required by section 403(w)(1) of the Act, 21 U.S.C. § 343(w)(1). Specifically, the product label fails to identify the major food allergens: fish and Crustacean shellfish.
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines major food allergens as: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient containing 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 bearing or containing a major food allergen, unless either:
(A) The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients, section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A), or
(B) 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., “Pollock (fish) or crab (Crustacean shellfish)”), except 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 from which the major food allergen is derived or the name of the food source from which the major allergen is derived appears elsewhere in the ingredient list (unless the name of the food source appearing 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).
Your Spreadable Lobster Bisque, Spreadable Shrimp Scampi, and Spreadable Crab Creole products 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 and the label fails to bear the common or usual name of each ingredient in accordance with 21 CFR 101.4(a)(1). For example:
- Spreadable Lobster Bisque: According to documents collected during the inspection of your firm, your product contains a lobster base. The lobster base is a multi-component product; however, your label fails to list all the components listed in the lobster base. For example:
- Butter (Sweet Cream, Salt)
- Spreadable Crab Creole: According to documents collected during the inspection of your firm, your product contains a crab base. The crab base is a multi-component product; however, your label fails to list all the components listed in the crab base. For example:
- Butter (cream, salt, lactic acid)
- Spreadable Shrimp Scampi: According to documents collected during the inspection of your firm, your product contains a shrimp base. The shrimp base is a multi-component product; however, your label fails to list all the components listed in the crab soup base. For example,
- Butter (cream, lactic acid)
For ingredients that are themselves composed of two or more ingredients, (e.g., mayonnaise), the requirement to list the component ingredients (or “sub-ingredients”) may be met by either (1) parenthetically listing the component ingredients after the common or usual name of the main ingredient, 21 CFR 101.4(b)(2)(i), or (2) 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. 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.
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.
We also note the following:
- The “CONTAINS” statement on your Spreadable Lobster Bisque, Spreadable Crab Creole and Spreadable Shrimp Scampi products immediately follows the ingredient statement. Such a statement must be separate from the ingredient statement rather than immediately following the ingredient statement as to give the appearance of being included within the ingredient statement, 21 CFR 101.2(e).
- The “CONTAINS” statement on your Spreadable Lobster Bisque product does not include egg. Although egg is listed in the ingredient statement, if, in addition to listing the allergen source in your ingredient statement, you also use a “Contains” statement, all allergen sources must also be listed in the “Contains” statement.
Please Note: Your firm’s HACCP plan for Lobster Bisque, Shrimp Scampi and Crab Creole cheese spreads does not list the critical control point of Processing which includes weighing, batching, mixing, filling and packaging to ensure the acidity or equivalent measurement of the product for controlling the food safety hazards of Clostridium botulinum. It appears that (b)(4) may be a formulation control. If so, FDA recommends that the final pH of the products be at or below 5.0, as a secondary barrier to toxin formation.
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 and the Current Good Manufacturing Practice regulation (21 CFR Parts 123 and 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to Compliance Officer Rebecca L. Caulfield at the address on this letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612) 758-7194.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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