Inspections, Compliance, Enforcement, and Criminal Investigations
ADAO, Inc. 5/6/11
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
1. Pests must not be allowed in any area of a food plant, and effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c). However, your firm failed to exclude pests from the kitchen, old dairy cooler room, hummus production room, delivery dock, warehouse, and garage. For example:
2. Your firm failed to provide adequate screening or other protection against pests to comply with 21 CFR 110.20(b)(7). Specifically:
• The exterior kitchen door exiting to the outside trash compactor did not close adequately once the door had been opened, leaving variable gaps open to the outside; a gap of approximately 86 inches in height and a maximum of 2 inches in width was on the west side of the southern old dairy cooler rolling door; and a hole, approximately 18 inches in height and 12 inches wide was in the northwest wall of the kitchen, near the exterior door.
During the inspection closeout meeting on 12/22/2010 you stated that all stored product was removed from the dairy cooler room and the room's floor was washed. Your response to FDA on 1/14/2011 indicated you (b)(4) pest control services, and plan to hire (b)(4) to replace your exterior doors and cooler door. Your response also notes that you are in the process of filling interior holes and installing new gaskets on doors, that you have cleaned and sanitized all the areas where mouse droppings were found, removed all clutter from the old dairy cooler room and main warehouse, and have sealed the interior entry point to the garage with a sliding door and new gaskets. However, your response is inadequate in that you have not provided a timeframe for when all the repairs will be completed.
• In the garage you stored boxes containing personal belongings and wooden pallets holding flattened boxes, office equipment, an aquarium, a raised garden bed containing dirt, an unused refrigerator and other extraneous materials on 12/20/10.
• Unused wooden pallets, piles of soil and vegetation debris, trash, and other debris were along the southwestern exterior wall.
During the closeout meeting on 12/22/10 you stated that the dirt from the community garden, which is in close proximity to the building along the southwestern side of the facility, was removed. However, your response is inadequate in that you have not addressed whether you have removed all the soil and vegetation debris from the exterior of your building, and you have not provided a timeframe for the removal of any other debris present and adjacent to the exterior of your building.
4. Your firm is not constructed in such a manner as to allow floors and ceilings to be adequately cleaned and kept clean and kept in good repair to comply with 110.20(b)(4). Specifically:
• The kitchen and hummus production room floors are comprised of brick that was cracked, missing grout, and unsealed, and does not allow for the floors to be adequately cleaned. Food debris was observed between the unsealed bricks in both rooms.
• Two ceiling tiles were missing on the north side of the kitchen, creating an opening to the space above the ceiling.
During the closeout meeting on 12/22/10 you stated that employees use bleach when mopping the floor and that you purchased ceiling tiles. Your response received 1/19/11 indicated you are
in the process of re-grouting the floors and replacing some ceiling tiles in the main kitchen. FDA recommends all flooring in food preparation and storage areas be smooth, non-absorbent, easily cleanable and durable (e.g., no cracks). Your responses are inadequate in that the documents do not provide specific details of your corrections to flooring in the kitchen and production room, or replacement of ceiling tiles. In addition, you have not provided a timeframe for completion of the corrections.
5. Your firm failed to handle work-in-progress in a manner that protects against contamination to comply with 21 CFR 110.80(b)(5). Specifically, celery was draining in the right basin of the kitchen's 2-compartment sink where an employee was washing hands in the left basin sink adjacent to the celery. A second employee rinsed and drained red peppers in the same basin used for hand washing. Soiled food equipment and utensils were stored on the drain board adjacent to the left 2-compartment basin.
In addition, we have reviewed the labels for your Double Cheese Stack and Grilled Chicken & Provolone Cheese sandwiches, and your Mediterranean and Mandarin Orange salad products, and determined that they are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343]. Specifically,
6. Your Double Cheese Stack and Grilled Chicken & Provolone Cheese sandwiches and your Mediterranean and Mandarin Orange salad 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 deli products fail to declare completely or accurately the known major food allergens they contain, specifically milk, soy, egg, wheat, and tree nuts.
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 is listed but not as a major part of the name of an ingredient which is not required to be declared as a major food allergen) [Section 403(w)(1)(B) of the Act; 21 U.S.C. § 343(w)(1)(B)].
• The Double Cheese Stack sandwich includes cheddar and pepper jack cheese (which contain milk) and mayonnaise (from a container that bears the statement "contains egg"). According to the wholesale menu this product is available on whole wheat bread. The revised label provided during the inspection bears the statement "Contains wheat and milk products", but fails to declare the allergen "egg."
• The Grilled Chicken & Provolone sandwich includes chicken, provolone cheese (which contains milk), mayonnaise (from a container that bears the statement "contains egg") and according to the wholesale menu, is available on whole wheat bread. The revised label provided during the inspection bears the statement "Contains wheat and milk products", but fails to declare the allergen "egg".
• The Mediterranean salad includes pita bread (from a package that declares "Contains: wheat, milk, and soy".) The revised label provided during the inspection states, "Contains milk ingredients," but fails to declare "wheat" and "soy," which are declared on the pita bread product label.
7. Your Double Cheese Stack and Grilled Chicken & Provolone Cheese sandwiches and your Mediterranean and Mandarin Orange salad 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, but the labels fail to bear the common or usual name of each ingredient as required under 21 CFR 101.4. For example:
• Your Grilled Chicken & Provolone Cheese and Double Cheese Stack sandwich ingredient statements declare mayonnaise, which is a multi-ingredient component. Your labels for these products fail to include soybean oil, water, com syrup, egg yolk, vinegar, salt, spice, calcium disodium EDTA, all of which are sub-ingredients contained in the mayonnaise which is used in the manufacture of these two products. In addition, provolone cheese and the "cheese" in your Double Cheese Stack are foods comprised of sub-ingredients that are not listed on your finished product label's ingredient statement [21 CFR 101.4(b)(2)].
• Your Mediterranean salad ingredient statement fails to include cherry tomatoes, which are contained in the product according to your wholesale menu. Furthermore, the pita bread, feta cheese, and balsamic vinaigrette dressing are foods comprised of several sub-ingredients, which are not listed on your finished product label [21 CFR 101.4(b)(2)].
• Your Mandarin Orange and Mediterranean salad ingredient statements fail to include the types of organic greens contained in the product. Specifically, your label reads "with Organic Greens", but there is no reference to any "Organic Greens" in the list of ingredients.
• Your Grilled Chicken & Provolone Cheese and Double Cheese Stack sandwich ingredient statements are made with bread, which is a food comprised of several sub-ingredients, which are not listed on your finished product label [21 CFR 101.4(b)(2)].