| 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 Telephone: 303-236-3000 FAX: 303-236-3551 |
Department of Health and Human Services
May 6, 2011
Ref: DEN-11-12 WL
WARNING LETTER
VIA UPS
Mr. David L. Karas, Owner/President
ADAO, Inc.
3215 East 42nd Avenue
Denver, Colorado, 80216
Dear Mr. Karas:
The Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 3215 East 42nd Avenue, Denver, Colorado, on December 15-17th and 20-22nd, 2010. Our investigation found serious violations of the Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing, or holding of human food, Title 21, Code of Federal Regulations, Part 110 [21 CFR 110]. These violations cause the products manufactured in your facility to be 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)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health.
Furthermore, during the inspection, our investigators collected labels of your food products. Our review of the labels and other evidence collected during the inspection indicate that your firm’s Double Cheese Stack, Mediterranean, Grilled Chicken & Provolone Cheese, and Mandarin Orange products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] and its implementing regulations in 21 CFR Part 101. You may find the Act and its implementing regulations through links on FDA’s website at http://www.fda.gov.
Your significant violations include:
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:
• Eleven apparent rodent excreta pellets were observed in a plastic tote containing packages of elbow pasta, bowtie pasta, and rice paper.
• At least 4 apparent rodent excreta pellets were observed in a clear plastic container holding cleaned and sanitized utensils intended to be used during food production.
• Apparent rodent excreta pellets too numerous to count were observed along the entire perimeter of the old dairy cooler room.
• Approximately 154 apparent rodent excreta pellets were observed in the southeast corner of the hummus production room, underneath and behind food storage and equipment racks; 54 apparent rodent excreta pellets were found along the southwestern portion of the hummus production room; and 14 apparent rodent excreta pellets were observed along the raised curb on the southern side of the hallway leading into the hummus production room and the kitchen from the warehouse.
2. Your firm failed to provide adequate screening or other protection against pests to comply with 21 CFR 110.20(b)(7). Specifically:
• There was a gap of 12 inches in height and 14 to 1 inch in width between the metal frame and gasket on the west side of the loading dock door, and a gap of 90 inches in height and a maximum of 2 inches in width between the metal frame and gasket on the east side of the loading dock door.
• 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.
3. Your firm failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests within the immediate vicinity of the plant buildings or structures to comply with 21 CFR 110.20(a)(1). Specifically:
• 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.
Misbranding
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)].
For example:
• 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 Mandarin Orange salad contains a tofu ingredient (which is made from soy) and walnuts. The revised label provided during the inspection, bears the statement "Contains 'nuts, soy, and milk ingredients." However, section 403(w) of the Act requires that the specific tree nut be declared, and the revised label fails to make the appropriate declaration for the specific tree nut.
• 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)].
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.
In addition, we note that your product labels must declare the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. For example, the statement of the place of business must include the street address, city, State, and ZIP code. Some of your labels in use at the time of the inspection list only the location of the business as Denver, CO 80222. The street address may be omitted if it is shown in a current city directory or telephone directory. In addition, you fail to provide the name of your business (ADAO, Inc.) on your product labels. Unless your line names, e.g., (b)(4) are names of the manufacturer, packer, or distributor, these products of yours are misbranded.
Your January 14, 2011 response to the FDA 483 partially addresses the above labeling deficiencies. You did not submit labeling corrections for all the food products identified as non-compliant during the inspection or at minimum demonstrate correction has been achieved. We only received the extended ingredient lists for your microwavable “World b’eatin” meals. In addition, based on the proposed corrections you submitted, your “Contains” statement and/or “Allergy Warning” in the extended ingredient lists for your microwavable “World b’eatin” meals are not declared in accordance with Section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)].
The above violations are not meant to be an all-inclusive list of deficiencies in your plant and on your product labels. It is your responsibility to ensure that your processing plant operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations, including the Good Manufacturing Practice regulations (21 CFR Part 110). You should take prompt action to correct all of the violations noted in the letter. Failure to do so may result in regulatory action without further notice, including but not limited to, seizure and/or injunction.
Please 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 deviations. You should include in your response any documentation, such as records, revised labels, photographs, 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 written reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024.
Sincerely,
/S/
Mark R. Madson
Acting District Director
Denver District Office
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