| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor bay Parkway Alameda, CA 94502-7070 Telephone: 510-337-6700 |
Department of Health and Human Services
May 18, 2011
WARNING LETTER
VIA UPS
Steven K. Cutter, President and CEO
Natural Choice Distribution Company
5427 Telegraph Avenue, Suite U
Oakland, CA 94609
Dear Mr. Cutter:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility, located at 5427 Telegraph Avenue, Suite U on February 8 through February 22, 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). You may find the Act, the seafood HACCP regulations and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Furthermore, labels for your Fare & Square Albacore Tuna sandwich with Ginger Wasabi, Superfresh Foods! Vegetarian Smoked Turkey sandwich, and Real Wraps Burrito Grande, products were collected during the inspection. Our review of the labels and other evidence collected during the inspection find that these products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and its implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).
Your significant violations were as follows:
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 albacore tuna with ginger wasabi sandwich to control the food safety hazards of pathogens and Histamine toxin.
2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor for the prevention of cross contamination from insanitary objects to food, food packing material, and other food contact surfaces, including utensils, gloves, and outer garments, and raw products to cooked products; maintenance of hand sanitizing; protection of food contact surfaces from adulteration with biological contaminants; and exclusion of pest with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110] as evidenced by:
a) Bins were set to dry on metal racks in direct contact with black and pink colored mold-like material on the walls.
b) Your employees were observed packing Superfresh Foods brand Red Potato Salad from white plastic bins that were dirty on the outer surfaces of the bins with black residue. After sanitizing the bins, the black residue remained on the bins, and then employees were observed using the bins to hold chicken salad, mixed albacore tuna salad, and lettuce.
c) Employees were observed stacking bins so that the outer dirty surface of one bin was in direct contact with the inner surface of the next bin.
d) Employees were observed touching the inside surfaces of garbage cans containing garbage then continue assembling sandwiches without washing or sanitizing their hands. In addition, employees were observed touching their faces with glove and bare hands then continue assembling sandwiches without washing and sanitizing their hands.
e) Lack of hand sanitizer in the Assembly and Packing room.
f) Failure to sanitize food contact equipment. Employees were observed using a three compartment sink, but had bypassed the automatic sanitizer dispenser so that there was no measureable amount of sanitizer in the sink.
g) Flies were observed flying in the Assembly Room during manufacturing and a three by eight inch hole in the metal bay door separating the assembly room from the outside of the facility.
Misbranding
We have reviewed the labels for your Fare & Square Albacore Tuna with Ginger Wasabi Sandwich, Superfresh Foods! Vegetarian Smoked Turkey Sandwich, and your Real Wraps Burrito Grande products and determined that they are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Specifically,
3. Your Fare & Square Albacore Tuna with Ginger Wasabi Sandwich, Superfresh Foods! Vegetarian Smoked Turkey Sandwich, and your Real Wraps Burrito Grande products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the labels for your ready-to-eat deli style products fail to declare completely or accurately the known major food allergens: milk, soy, egg, and wheat as specified by 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 the exception of highly refined oils or ingredients derived from such 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:
• 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, 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 from which the major food allergen is derived 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 a food ingredient that is not a major food allergen by definition) section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
Your Fare & Square Albacore Tuna with Ginger Wasabi Sandwich is made with whole grain bread and mayonnaise which contain sources of wheat, soy, and eggs that are not declared on the product label as major allergen sources. Your Superfresh Foods! Vegetarian Smoked Turkey Sandwich and your Real Wraps Burrito Grande are made with Monterey Jack cheese which contains milk. However, milk is not declared on the product label as a major allergen source.
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
4. Your Fare & Square Albacore Tuna with Ginger Wasabi Sandwich, Superfresh Foods! Vegetarian Smoked Turkey Sandwich, and your Real Wraps Burrito Grande 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 labels fail to declare the common or usual name of each ingredient as required by 21 CFR 101.4(b). For example:
• The ingredient statements for your Fare & Square Albacore Tuna with Ginger Wasabi and Superfresh Foods! Vegetarian Smoked Turkey Sandwiches declare tuna (Fare & Square only), Dijon mustard (Superfresh only), whole grain bread and canola oil mayonnaise, which are multi-ingredient components.
• Your Fare & Square Albacore Tuna with Ginger Wasabi ingredient statement declares albacore tuna, which is a multi-ingredient component. Your label for this product fails to include vegetable broth (pea and carrot extract) and salt, all of which are sub-ingredients contained in the albacore tuna which is used in the manufacture of this product.
• Your Superfresh Foods! Vegetarian Smoked Turkey Sandwich and Real Wraps Burrito Grande ingredient statements declare Monterey jack cheese or jack cheese free of artificial hormones (rBGH), and shoyu which are multi-ingredient components.
• Your Real Wraps Burrito Grande product fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4(a)(1). For example: the “citrus juice” and “jack cheese free of artificial hormones (rBGH)” are not the common or usual name for these ingredients.
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, or by listing the component ingredients without listing the 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.
For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm
5. Your Fare & Square Albacore Tuna with Ginger Wasabi and Superfresh Foods! Vegetarian Smoked Turkey Sandwiches are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that your products fail to provide nutrition facts information in accordance with 21 CFR 101.9.
In addition, your Real Wraps Burrito Grande is further misbranded because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Specifically:
• The Calories are not expressed to the nearest 10 cal increment [21 CFR § 101.9(c)(1)];
• The Calories from fat are not expressed to the nearest 10 cal increment [21 CFR § 101.9(c)(1)(ii)];
• The Cholesterol is not expressed to the nearest 5 mg increment [21 CFR § 101.9(c)(3)];
• The Sodium is not expressed to the nearest 10 mg increment [21 CFR § 101.9(c)(4)];
• Calcium and Iron are not expressed to the nearest 5-percent increment for products declaring above 10 percent and up to and including 50 percent of the RDI as required [21 CFR 101.9(c)(8)(iii)].
Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemption in 21 CFR 101.9(j)(18) [or see http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/SmallBusinessNutritionLabelingExemption/default.htm] for information on filing for an annual exemption. The application may be submitted online at: https://info1.cfsan.fda.gov/nle/client/login.cfm. We have no record of your firm having filed a Small Business Nutrition Labeling Exemption Notice.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant and on your product labels. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. We may take further action without notice 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 addition, your Superfresh Foods! Vegetarian Smoked Turkey Sandwich and Real Wraps Burrito Grande ingredient statements declare Monterey jack cheese or jack cheese free of artificial hormones (rBGH), which are multi-ingredient components that contain coloring. Although voluntary, we recommend you declare all colorings added to your Monterey jack cheese, such as the annatto [21 CFR 101.22(k)(3)].
Your Superfresh Foods! Vegetarian Smoked Turkey Sandwich contains false and misleading statements. In particular, your product name “Vegetarian Smoked Turkey…” is not an appropriately descriptive term of this food because it is not made with turkey [21 CFR 101.3(b)(3)].
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: Darlene B. Almogela, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issues in this letter, please contact Compliance Officer Sergio Chavez at (510) 337-6886.
Sincerely,
/s/
Barbara Cassens
District Director
San Francisco District Office
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