Inspections, Compliance, Enforcement, and Criminal Investigations
Dobake Bakeries, Inc. 2/16/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
16 February 2011
DELIVERY SIGNATURE REQUESTED
Daniel W. Giraudo, President
Dobake Bakeries, Inc.
810 81st Ave.
Oakland, CA 94621
RE: Dobake Bakeries, Inc.
Dear Mr. Giraudo:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food processing and storage facility, located at 810 81st Avenue, Oakland, CA, from October 26, 2010 to November 2, 2010. During this inspection, FDA investigators collected labels for several of your products. Based on our review of these labels, we have determined that your "(b)(4) Raw Almond Croissants" and Elegant Pastries brand "Banana Walnut Loaf Cake" products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links at FDA's Internet home page at http://www.fda.gov.
Specifically, your (b)(4) Raw Almond Croissants and Elegant Pastries Banana Walnut Loaf Cake products are misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the statements of identity that are used in the products' labeling, "Raw Almond Croissants" and "Banana Walnut Loaf Cake," respectively, are false and misleading. "Almond" and "Banana" are the characterizing flavors of these products as set forth in 21 CFR 101.22(i). However, the formulations of these products do not include almond or banana, respectively, but instead include artificial and natural flavors. Therefore, the characterizing flavors of your (b)(4) Raw Almond Croissants and Banana Walnut Loaf Cake products must be identified in accordance with 21 CFR 101.22(i) to prevent these products' labels from being false and misleading. Specifically, if the food contains natural flavor derived from the characterizing ingredient and an amount of the characterizing ingredient insufficient to independently characterize the food, or the food contains none of the characterizing ingredient, the name of the characterizing flavor may be immediately preceded by the word "natural" and must be immediately followed by the word "flavored" (e.g., "natural banana flavored cake") [21 CFR 101.22(i)(1)]. If the food contains any artificial flavor which simulates, resembles, or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the label must be accompanied by the common or usual name(s) of the characterizing flavor, which shall be accompanied by the word(s) "artificial" or "artificially flavored" (e.g., "artificial banana," or "artificially flavored banana") [21 CFR 101.22(i)(2)].
The violations cited in this letter may not be all-inclusive of violations at your facility or in your labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of the Act and FDA regulations. Failure to correct violations may result in regulatory action being initiated by FDA without further notice. For example, we may seize your products and/or enjoin your firm from operating.
In addition, we note that investigators observed live insects and apparent rodent pellets within your firm during the inspection. Specifically, investigators observed approximately six live insects, two of which appeared to be cockroaches, crawling behind a pipe below the hand washing sink in the mixing room. This hand washing sink is approximately five feet away from the rheon and bread lines, which are used to produce croissant and bread dough. At the time the insects were observed, butter croissant dough was being produced on the rheon line.
Investigators also observed 10 black, dull apparent rodent pellets in the raw ingredients receiving warehouse. Four apparent rodent pellets were located directly beside a pallet of (b)(4) Muffin Mix and a pallet of (b)(4) Brownie Mix. One apparent rodent pellet was located on top of a bag of the same Muffin Mix. Two apparent rodent pellets were located beneath a pallet of (b)(4) Brownie Base. We acknowledge that you have recently increased your efforts to monitor and exclude pests from your facility, and note that such efforts are required under 21 CFR 110.35(c) in order to prevent your products from becoming adulterated within the meaning of Sections 402(a)(3) and 402(a)(4) of the Act [21 U.S.C. §§ 342(a)(3) & (4)]. We encourage you to continue those efforts, and will verify the results of your increased efforts at our next inspection.
Further, we offer the following comments on your labeling:
• We reviewed the label for your Butter Vanilla Loaf Cake product. The statement of identity and ingredient statement for this product does not appear to comply with the requirements of 21 CFR 101.22. We consider the name "Butter ________" or the use of the word butter, without qualification, in conjunction with a product's name to be false and misleading unless all of the shortening ingredient used in the product is butter. If the product contains both butter and an alternative shortening ingredient but a sufficient amount of butter to give a characteristic butter flavor to the product, the appropriate name for the product would be "butter flavored ______" However, if the product contains any artificial butter flavor, it should be labeled in compliance with 21 CFR 101.22(i)(2).
• All required information (ingredient list, nutrition information and the name/address of the manufacturer) appearing on the information panel must be in one place without any intervening material [21 CFR 101.2(e)]. However, the following statements are intervening material because they separate required information: "Manufactured on equipment that processes peanuts," on the Walnut Loaf Cake and the Butter Vanilla Loaf Cake product labels; and "Allergy information," and "Manufactured on equipment that processes peanuts and tree nuts" on the Almond Croissant product labels.
• The Banana Walnut Loaf Cake label states: "ALLERGENS: Wheat, Milk, Eggs, Soy, Tree Nuts." This statement does not appear to be consistent with the requirements set forth in section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)], which provides that the presence of a major food allergen in a product may be declared by the word "Contains," followed by the name of the food source from which the major food allergen is derived, printed immediately after or adjacent to the list of ingredients. Section 403(w)(2) of the Act [21 U.S.C. § 403(w)(2)] further provides that the term "name of the food source from which the major food allergen is derived" means the name of the specific type of nut in the "Contains" statement (i.e., "walnut"). We note that "walnuts" are declared in both the product identity and the ingredient statement of the Banana Walnut Loaf Cake product label, while the term "Tree Nuts" is used in the "Allergens" statement.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct these violations and to prevent the recurrence of these or similar violations. Please explain and include documentation of any corrective action you have taken. If additional planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.
Please respond to Warren E. Savary, Compliance Officer, Food and Drug Administration, at the above address. Any questions you may have regarding this letter should be directed to Mr. Savary at (510) 337-6821, or via email to Warren.Savary@fda.hhs.gov.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration