Inspections, Compliance, Enforcement, and Criminal Investigations
Whatsa Bagel, Inc. 5/14/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
May 14, 2013
Return Receipt Requested
Mr. Stephen Fleishman, President
Whatsa Bagel, Inc.
9226 Gaither Road
Gaithersburg, MD 20877
Dear Mr. Fleishman:
We inspected your firm, a manufacturer of ready-to-eat (RTE) bagels, located at 9226 Gaither Road, Gaithersburg, MD on February 6, 7, 11, and 14, 2013. The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation in manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause the foods manufactured at 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 were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. Further, FDA conducted a review of your labeling for several of your bagel products and found significant violations of the labeling regulations for foods, 21 CFR 101. These violations cause your retail-packaged bagels, to be misbranded within the meaning of section 403 of the Act, 21 U.S.C. § 343. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
Specifically, our inspection of your facility revealed the following cGMP violations:
1.) Your firm failed to use pieces of equipment that are designed to be adequately cleanable, and properly maintained as required by 21 CFR 110.40(a). Specifically, our Investigator observed that you store uncooked bagels on plywood proofboards and baking boards (b)(4).
Your firm’s response, received March 14, 2013, noted that plywood proofboards will be replaced with plastic trays. However, your response does not address the continued use of baking boards. (b)(4) are not appropriate materials for manufacturing food products as they are porous and difficult to clean. In addition, they tend to shed particles over time that can contaminate your food products.
2.) Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces as required by 21 CFR 110.35(a). Specifically, our Investigator observed that your firm does not clean and sanitize between use the plywood proofboards, baking boards, or plastic trays that are used to manufacture your bagel products.
Your firm’s response noted that you will be purchasing cleanable, colored plastic trays to replace the plywood proofboards and trays you are currently using. As mentioned earlier, (b)(4) are not appropriate materials for manufacturing food products.
1.) Your bulk, RTE bagels are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that you failed to declare all major food allergens present in these products.
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 ingredients containing proteins 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 (e.g. “flour(wheat)”), 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 (e.g. “wheat flour”), or the name of the food source that 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)].
Your products are packaged in unlabeled paper bags within plastic bags and fail to declare the presence of the major food allergens wheat, eggs, milk, soy, and tree nuts, as follows:
• All of your bulk packaged bagels contain (b)(4)
• Your egg bagels contain (b)(4)
• Your cheese bagels contain (b)(4)
• Your granola bagels contain (b)(4)
• Your French toast bagels contain (b)(4)
2.) Your bulk, packaged RTE bagels are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that they fail to bear a statement of identity. The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity [21 CFR 101.3(a)].
3.) Your bulk, packaged RTE bagels are misbranded within the meaning of section 403(e) of the Act [21 U.S.C. 343(e)] in that they fail to bear a label containing (1) the name and place of business of the manufacturer, packer, or distributor [21 CFR 101.5]; and (2) an accurate statement of the net quantity of the contents in terms of weight, measure, or numerical count [21 CFR 101.105].
Your firm’s response did not discuss any corrective actions to address these misbranding violations.
We may take further action 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.
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. 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.
In addition, we note the following on the labels that you distribute to customers upon request:
• FDA requires foods that contain a major food allergen to declare the presence of that allergen on food labels. FDA does not address the use of advisory labeling, including the presence of unintentional ingredients in food products resulting from the food manufacturing process. Use of such statements is voluntary and at the discretion of the manufacturer, provided that they are not false or misleading. FDA would expect firms to adhere to good manufacturing practices designed to prevent or reduce the possibility of major food allergens accidentally becoming incorporated into foods not formulated to contain those food allergens as ingredients. Please see: http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/default.htm for more information.
• The labels for your “Granola” and “Banana Nut” bagel products include the statement “Contains Nuts, Wheat.” If included on the label, the “Contains” statement must identify the names of the food sources for all major food allergens that are either in the food or are contained in ingredients of the food. Instead of saying “Nuts,” the “Contains” statement should identify the specific tree nut, (b)(4), present in these products.
• The labels for your “Cheese” bagel product declare “Grated Romano Cheese, Grated Parmesan Cheese.” These are multi-ingredient foods, but your labels fail to declare the sub-ingredients of these foods. According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either (1) parenthetically listing the component ingredients after the common or usual name of the main ingredient, or (2) 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.
• The ingredient listing has intervening information, which should not be included, per 21 CFR 101.2(e). Your ingredient statements, in part, include the following intervening material (see underlined words):
o On all product labels “Yeast (Trace Quantities of Starch and Salt)”
o On your “Whole Wheat” and “Whole Wheat E/t” bagels, “Stone Ground Spring Whole Wheat Flour, Course Wheat Flour”
• We note that the ingredient “Hi Gluten Flour” in all of your RTE bagel products should be spelled as “High Gluten Flour”.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We also note that when allergens that are not specifically formulated in a food are identified as likely to occur in the food because of manufacturing practices, the manufacturer should identify and implement controls to reduce or prevent allergen cross-contact. Examples of preventive measures include production scheduling and dedicated equipment for production runs of products for which cross-contact is a concern, and proper cleaning. For more information, see Compliance Policy Guide Section 555.250 which can be found at the following web address: (www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074552.htm)
FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please send your reply to the U.S. Food and Drug Administration, Attention: Ernest F. Bizjak, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Bizjak by phone at 410-779-5715 or by email at firstname.lastname@example.org.
Baltimore District Office