Inspections, Compliance, Enforcement, and Criminal Investigations
Sugar Bakers, Inc. 3/19/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
6000 Metro Drive, Suite 101
Baltimore, MD 21215
March 19, 2012
RETURN RECEIPT REQUESTED
Ms. Jamie Williams, Owner
Sugar Bakers, Inc.
23 Mellor Avenue
Catonsville, MD 21228
Dear Ms. Williams:
An investigator from the Baltimore District Office of the United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 23 Mellor Avenue, Catonsville, MD, 21228, from December 21-22, 2011 and January 4, 2012. During our inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, your Smith Island Cake and Caramel Apple Pecan Coffeecake 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). You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.
Your significant violations are as follows:
1. Your firm failed to store your in-process and finished food products under conditions and controls necessary to minimize the potential for the growth of microorganisms, or for the contamination of food as required by 21 CFR 110.80(b)(2). Specifically, our investigators observed the following situations which could potentially lead to the contamination of your bakery products:
a Approximately three rows of uncovered baked yellow cakes located in the oven room, were stored directly under plastic packing containers and baking racks coated in apparent filth;
b. A trash can, located in the preparation room, was stored in close proximity to the mixer used to combine raw ingredients into the batter, and,
c. Two buckets of uncovered yellow cake batter were stored atop a table located in the preparation room located directly next to the plastic storage containers that were coated with apparent filth and dried cake batter.
2. Your firm failed to locate and operate your fans in a manner that minimizes the potential for contaminating food and food-contact surfaces as required by 21 CFR 110.20(b)(6). Specifically, our investigators observed the following situations which could potentially lead to the contamination of your bakery products:
a. A small white fan, coated in apparent dirt/dust, located in the preparation room was blowing air onto uncovered, unbaked pie crust and baked yellow cakes;
b. A large black fan, coated in apparent dirt/dust, located in the oven room was stored on top of a baking rack which is used to cool uncovered baked good; and,
c. A small black fan, coated in apparent dirt/dust, located on the decorating table in the decorating room was blowing air onto a baked uncovered carrot cake.
3. Your firm's employees did not wash their hands thoroughly after times when their hands may have become soiled or contaminated as required by 21 CFR 110.10(b)(3). Specifically, on two separate occasions, our investigator observed employees using personal cell phones and not washing their hands or changing gloves before handling finished product.
1. Your Smith Island Cake and Caramel Apple Pecan Coffeecake products are misbranded within the meaning of section 403(w) of the Act [21 U.S. C.§ 343(w)] in that the product labels fail to identify the major food allergens of wheat, eggs, milk, soy, and pecans as required by section 403(w)(1).
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines "major food allergens" as milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans; as well as any food ingredient containing protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient bearing or containing, a major food allergen, unless either:
a. The word "contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [Section 403(w)(1)(A) of the Act; 21 U.S.C. § 343(w)(1)(A)]; or
b. 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., "Enriched Flour (Wheat)"), except 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)].
Tree Nuts and Wheat: The formulation information for your Caramel Apple Pecan Coffeecake product indicates that pecans and Pillsbury Flour, which contains bleached wheat flour, are ingredients in this product. Wheat, Eggs, Milk and Soy: The formulation information for your Smith Island Cake product indicates that Pillsbury Baker's Plus Yellow Cake mix, which contains wheat flour, egg white, nonfat milk, and soy flour, are ingredients in this product.
2. Your Smith Island Cake and Caramel Apple Pecan Coffeecake products are misbranded within the meaning of section 403(i)(2) of the Act [21 USC 343(i)(2)] because they are fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight, as well as sub-ingredients, as required by 21 CFR 101.4.
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 [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 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.
3. Your Smith Island Cake and Caramel Apple Pecan Coffeecake products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] in that they fail to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
4. Your Smith Island Cake and Caramel Apple Pecan Coffeecake products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that they fail to bear a statement of the net quantity of contents in terms of weight, measure, or numerical count in accordance with 21 CFR 101.105.
We also offer the following comments regarding your product labels:
• The menu labeling for your Smith Island Cake product indicates the product is made with the ingredient peanut butter cups. Peanuts are considered a major food allergen in accordance with Section 201(qq) of the Act [21 U.S.C. § 321(qq)]. If your Smith Island Cake product contains peanuts or other major food allergens, they must be declared in accordance with the requirements of the Act, as amended by the Food Allergen Labeling and Consumer Protection Act.
• Your Smith Island Cake product fails to bear a finished product label containing the common or usual name of the food in accordance with 21 CFR 101.3(b). Shorthand abbreviations such as "yell/FBC" do not meet the requirement to include an appropriately descriptive product name, per 21 CFR 101.3(b)(3).
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and 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 violations. You should include in your response documentation, such as verification records and revised labeling, 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.
If you have any questions regarding the contents of this letter, please contact Randy Pack at 410-779-5417.