| Public Health Service Food and Drug Administration |
New England District One Montvale Avenue |
Department of Health and Human ServicesWARNING LETTER
NWE-25-11W
VIA UNITED PARCEL SERVICE
August 2, 2011
Cynthia Blackwood
Deshaies’ Associates, Inc.
dba Deshaies’ Lobster Salad
518 Sabattus Street
Lewiston, Maine 04240
Dear Ms. Blackwood:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 518 Sabattus Street, Lewiston, Maine on April 5, 2011 to May 4, 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 regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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 Seafood Stuffing and Seafood Salad products 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, during the inspection, we collected labels for several of your food products. Based on our review of the labeling for your products, your Processes Seafood Lobster Salad is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because it bears or contains an unsafe color additive. Further, your Deluxe (100%) Lobster Salad, Processes Seafood Lobster Salad, Seafood Stuffing, and Mr. Lobster™Brand Real Lobster Salad products are misbranded within the meaning of section 403 of the Act [21 U.S.C. 343].
You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in 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 a HACCP plan for your Seafood Stuffing product to control the food safety hazards of pathogen survival through cooking, pathogen growth and toxin formation (including Staphylococcus aureus and Clostridium botulinum), and allergens and food intolerance substances.
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 plan for your Seafood Salad product does not list the critical control points of the following:
a. (b)(4) for controlling the food safety hazard of pathogens, specifically Clostridium botulinum growth and toxin formation, because the products are received (b)(4).
b. Finished product cooler storage for controlling the food safety hazard of pathogen growth and toxin formation, including Clostridium botulinum growth and toxin formation associated with products packaged in (b)(4) containers that are held under refrigerated conditions.
c. Finished product labeling to control the food safety hazard of undeclared allergens and food intolerance substances. Your firm processes multiple types of seafood salads where allergens may vary with the end product. Consequently, rather than a critical control point for receipt of labels, FDA recommends that you list a “Finished Product Labeling” critical control point to ensure that finished product labels match the specific products and therefore accurately declares incorporated allergens.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for your Seafood Salad product lists a monitoring procedure at the (b)(4) critical control point that is inadequate to control pathogenic bacteria growth and toxin formation. Your HACCP plan lists a monitoring frequency of (b)(4) which is not adequate to control your identified food safety hazard of “Growth of pathogenic bacteria due to temperature abuse.” Monitoring temperatures (b)(4) does not ensure that proper temperatures were continuously maintained prior to that temperature check. Your plan should list that you will monitor cooler temperatures continuously with a temperature monitoring device and that you will review those records daily to assure that your critical limit has not been exceeded.
4. 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 your Seafood Salad product at the (b)(4) critical control point to control the formation of “Growth of Pathogenic Bacteria” is not appropriate. Specifically, your HACCP plan lists the corrective action as (b)(4). Your plan does not describe what will be done when temperatures are between (b)(4) (your critical limit is listed as (b)(4)). In addition, your plan should describe how the product will be evaluated for use. Microbiological testing is not considered sufficient as an evaluation method.
5. You must maintain sanitation control records which, 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 any sanitation monitoring records that document the monitoring and corrections set out in 21 CFR 123.11(b) for your seafood products on (b)(4).
6. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21CFR123.11(b). However, your firm did not monitor the following conditions and practices with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the observations listed below:
- Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments [21 CFR 123.11(b)(1). Specifically, our investigators observed:
i. dried food residue along the front and side edges of the scale used for weighing food; and
ii. rust, dried food residue, and flaking paint on the lobster meat (b)(4).
- Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments [21 CFR 123.11(b)(3)]. Specifically, our investigators observed:
i. an employee mixing lobster salad wearing an apron over a sweatshirt. The sweatshirt sleeves extended beyond the coverage of the apron and contacted the rim of the mixing tray; and
ii. the employee went outside of the facility wearing the apron under an outdoor coat and returned to mixing the lobster salad without changing, cleaning or sanitizing the apron.
- Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, and other chemical and physical compounds [21 CFR 123.11(b)(5)]. Specifically, our investigators observed that the label for the hydraulic oil used for the (b)(4) does not indicate it is a food grade or otherwise safe to use in a food-processing facility.
Misbranding Violations
7. Your Processes Seafood Lobster Salad product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare all major food allergens present in the product, as required by section 403(w)(1) of the Act. Specifically, your Processes Seafood Lobster Salad is manufactured with an imitation king crabmeat product, which contains crab; however, your label fails to declare this major food allergen.
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))].
8. Your Mr. Lobster™ Brand Real Lobster Salad is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the product fails to provide nutrition information in accordance with 21 CFR 101.9. For example:
- Your Mr. Lobster™ Brand Real Lobster Salad product label does not contain a statement of the number of grams of trans fat in a serving or if a statement of the trans fat is not required, your product does not contain the statement “Not a significant source of trans fat” at the bottom of the table of nutrient values [21 CFR 101.9(c)(2)(ii)]. More information regarding trans fat labeling can be accessed on our website at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053479.htm.
- Your Mr. Lobster™ Brand Real Lobster Salad product label does not declare the serving size in common household measure as required by 21 CFR 101.9(b)(7).
9. Your Processes Seafood Lobster Salad and Seafood Stuffing products are misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] in that each of these products is fabricated from two or more ingredients, but their labels fail to bear the common or usual name of each ingredient, as required by 21 CFR 101.4. Specifically, the product labels for your Processes Seafood Lobster Salad and Seafood Stuffing products fail to declare each of the sub-ingredients of the multi-ingredient foods used in the manufacture of these products (e.g. (b)(4) Imitation King Crabmeat, Ritz crackers, butter blend and garlic butter). 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)].
10. Your Processes Seafood Lobster Salad is misbranded within the meaning of section 403(x) of the Act [21 U.S.C. 343(x)] in that this product contains a coloring that bears or contains a food allergen (other than a major food allergen) that is not disclosed in accordance with 21 CFR 73.100(d). Specifically, your Processes Seafood Lobster Salad product contains, as an ingredient, (b)(4) Imitation King Crabmeat. The label for the (b)(4) Imitation King Crabmeat declares “carmine” as an ingredient. Carmine is a color additive that is an allergen for a subset of the allergic population. See 74 Fed. Reg. 207-01 (Jan. 5, 2009). Under 21 CFR 73.100(d)(2), the label of food products intended for human use that contain carmine must specifically declare the presence of the color additive by listing its respective common or usual name, “carmine,” in the statement of ingredients in accordance with 21 CFR 101.4. However, the label for your Processes Seafood Lobster Salad product fails to declare the presence of carmine.
Your Processes Seafood Lobster product is also adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because this product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive’s listing regulation. As noted above, your Processes Seafood Lobster Salad product contains the color additive carmine. The listing regulation for carmine requires that the color additive be listed by its common or usual name, “carmine,” in the statement of ingredients [21 CFR 73.100(d)(2)]. However, the label for your Processes Seafood Lobster Salad product fails to declare the presence of carmine in the statement of ingredients.
11. Your Seafood Stuffing is misbranded within the meaning of section 403(e)(1) [21 U.S.C. § 343(e)(1)], in that the packages do not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(a).
This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your processing plant and your food products comply with the Act and its implementing regulations, including the seafood HACCP regulation (21 CFR Part 123), the Current Good Manufacturing Practice regulation (21 CFR Part 110). You should take prompt action to correct the violations described in this letter and establish and implement procedures that will prevent them from occurring in the future. Failure to take appropriate corrective action may result in enforcement action without further notice, such as seizure or injunction.
We have the following comments about your product labels:
1. Your Seafood Stuffing is made with Ritz crackers, butter blend and garlic butter. If these ingredients contain major food allergens, you must ensure that they are disclosed in accordance with section 403(w) of the Act [21 U.S.C. § 343(w)].
2. During the inspection, you told our investigators that the bread you receive to make bread crumbs is not labeled; therefore, you could not provide information on the ingredients. You must ensure that your product labels accurately reflect the ingredients in your products in accordance with 21 CFR 101.4.
3. The label of the Mr. Lobster™ Brand Real Lobster Salad product states “May Contain Tripolyphosphate.” There is no provision in 21 CFR 101.4 permitting the use of a “may contain” statement with regard to the ingredient tripolyphospate. In general, absent an applicable exception, ingredients are required to be listed by common or usual name, without other intervening material, in descending order of predominance on either the principal display panel or the information panel on the label of a food [21 CFR 101.2(e); 21 CFR 101.4(b)].
4. The name of your Deluxe (100%) Lobster Salad product includes the percentage of the characterizing ingredient lobster. However, we note that your product contains ingredients other than lobster, such as mayonnaise and bread crumbs. You must ensure that the percentage of the characterizing ingredient or component is declared on the basis of its quantity in the finished product (i.e., weight/weight in the case of solids, or volume/volume in the case of liquids) in accordance with 21 CFR 102.5(b)(1).
5. The net weight declaration on your Mr. Lobster™ Brand Real Lobster Salad product does not appear as a distinct item on the principal display panel separated (by at least a space equal to the height of the lettering used in the declaration) from other printed label information appearing above or below the declaration [21 CFR 101.105(f)].
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 Food and Drug Administration, Attention: Bruce R. Ota, Compliance Officer at the above address. If you have questions regarding any issues in this letter, please contact Mr. Otaat 781-587-7487.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District
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