Inspections, Compliance, Enforcement, and Criminal Investigations
Chassy Bagels, Inc. dba House of Bagels, Inc. 9/7/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
September 7, 2012
Mr. Laurence B. Chassy, President
Chassy Bagels, Inc. dba House of Bagels, Inc.
1007 Washington Street
San Carlos, CA 94070
Dear Mr. Chassy:
The United States Food and Drug Administration (FDA) inspected your processing facility located at 1007 Washington Street, San Carlos, California, on February 2nd, 3rd, 7th, and 16th, 2012. 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 clean and use sanitizing agents as necessary to protect against the contamination of food as required by 21 CFR 110.35(d)(5). Specifically, our inspection revealed that your firm does not wash, rinse, and sanitize bagel processing equipment and utensils as frequently as necessary. For instance, your firm only scrapes and wipes with a wet rag the bagel former conveyor belt and metal mixing arms of the dough mixer; both are food contact surfaces. Dough residue was observed on the mixing arm of the dough mixer and the bagel former conveyor belts after the completion of cleaning operations. In addition, our investigator observed gray plastic crates, used to hold sliced ready-to-eat bagels, with leftover food debris. According to your production manager, these crates are only cleaned once a week.
2. Your firm failed to use equipments that are designed to be adequately cleanable, and properly maintained as required by 21 CFR 110.40(a). Specifically, our inspection revealed that you store uncooked bagels on wooden boards; some of which appear to be splintered with wooden slivers hanging in close proximity to product.
1. Your bulk, ready-to-eat 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)].
All of your bulk packaged bagels are made with wheat, and your egg bagels are made with eggs; however, they are packaged in unlabeled plastic bags within paper bags and fail to declare the presence of the major food allergens wheat and/or egg.
2. Your bulk, ready-to-eat packaged bagels and retail packages of “House of Bagels” Blueberry, Sesame, Poppy, Everything, Salt, Caraway, Plain, Jalapeno, Garlic, Onion, Whole Wheat Raisin, Whole Wheat Plain, and Egg Bagels 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. Specifically,
• Your bulk, ready-to-eat bagels packaged in unlabeled plastic bags within paper bags do not declare any ingredients.
• Your “House of Bagels” Plain bagels are made with enriched flour, a food for which a standard of identity has been established in 21 CFR 137.165, but is not declared as “enriched flour” as required by 21 CFR 101.4(a)(1). Your label declares “high gluten wheat flour.” In addition, if this flour is bleached, the name of the food should indicate that. Furthermore, enriched flour is a multi-ingredient food, but your label fails to declare the sub-ingredients of this food. According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either (i) parenthetically listing the component ingredients after the common or usual name of the main ingredient, or (ii) 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.
• Your “House of Bagels” Egg bagels are made with caramel color and egg shade; however your label does not include these ingredients as required by 21 CFR 101.4(a)(1).
• Your “House of Bagels” Egg bagels are made with pasteurized frozen whole eggs; however, your label incorrectly declares “whole fresh eggs.” This is not the proper common or usual name for this ingredient [21 CFR 101.4(a)(1) and (b)(10)].
• Your “House of Bagels” label is used for Sesame, Poppy, Everything, Salt, Caraway, Plain, Jalapeno, Garlic, Onion, Whole Wheat Raisin, Whole Wheat Plain, and Egg flavors; however, your label does not accurately list the ingredients used in these bagels. Your label states “(May contain less than 2% of the following: Onion, Garlic, Poppy Seeds, Sesame Seeds, Jalapeno Peppers, Blueberries, Rock Salt, Caraway Seeds.)” and “(May contain less than 2% of the following: California raisins). The use of “may contain” ingredient labeling is not provided by for 21 CFR 101.4.
If you wish to use one label for all of the above products, a "Catch-All" or "Shotgun" ingredient declaration may be used [see CPG Sec. 505.100@ http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074420.htm].
3. Your “House of Bagels” Egg bagels, bulk, ready-to-eat egg bagels, and frozen, uncooked egg bagels that are distributed on wooden boards are misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), because the products bear or contain artificial coloring but fails to bear labeling stating that fact. In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added must declare the coloring in the statement of ingredients. Your “House of Bagels” Egg bagels, bulk, ready-to-eat egg bagels, and frozen, uncooked egg bagels are made with caramel color and egg shade; however, your labels do not declare these colors or you fail to provide labeling declaring these colors.
4. Your bulk, ready-to-eat 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 quantity of the contents in terms of weight, measure, or numerical count [21 CFR 101.105].
Additionally, we have determined that your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During the previous inspection of your facility on December 2008 and during the current inspection you were (or your representative was) advised of this requirement. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. §331(dd)]. Our records indicate that, to date, this facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, register the facility with FDA immediately. Registration may be accomplished on-line at http://vvww.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
The above violations are not meant to be an all-inclusive list of deficiencies at your facility. You are responsible for ensuring that your products are in compliance with all applicable statues and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
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 CPG Sec. 555.250 which can be found at the following web address: (www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074552.htm)
We also note the following about your retail packaged “House of Bagels” labels:
• You told our investigator that the nutrient facts panel used on your retail labels was based on nutrition analysis for plain bagels. We question whether this information is accurate for all flavors of bagels that you package with these labels.
• The net quantity of contents statement on your labels fail to declare the weight in pounds with any remainder in terms of ounces or common or decimal fractions of the pound in parentheses after the declaration in ounces [21 CFR 101.105(j)(1)].
• The nutrition information is not set off in a box by use of hairlines as required by 21 CFR 101.9(d)(1)(i).
• The required headings, “Nutrition Facts,” “Amount Per Serving,” “% Daily Value,” “Calories,” “Total Fat,” “Cholesterol,” “Sodium,” “Total Carbohydrate,” and “Protein” is not highlighted by bold or extra bold type or other highlighting that prominently distinguishes it from other information as required by 21 CFR 101.9(d)(1)(iv).
• The heading “Nutrition Facts” is not set in a type size larger than all other print size in the nutrition label as required by 21 CFR 101.9(d)(2).
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved. If all corrective actions cannot be completed within fifteen working days, please state the reason for the delay and the time within which the corrections will be completed.
Your written response should be directed to Lawton Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Brandon L. Bridgman, Compliance Officer at 510-337-6794.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration
cc: State of California
Food and Drug Branch
California Department of Public Health