Inspections, Compliance, Enforcement, and Criminal Investigations
Biondillo's Bakery 4/17/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
April 17, 2014
DELIVERED VIA UPS NEXT DAY
Mr. Al Filin
Biondillo’s Bakery, LLC
4900 West Division Street
Chicago, IL 60651
Dear Mr. Filin:
The Food and Drug Administration (FDA) conducted an inspection of your facility, located at 4900 West Division Street, Chicago, Illinois on October 23, 2013 and November 7, 2013. During that inspection we found you had serious violations from FDA's Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations Part 110 (21 CFR 110). Based on the inspection findings, your food products are 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 become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, FDA collected product labels for your bakery products during the inspection of your facility. Our review of the labels found that your Focaccia Bread, Bread Crumbs, French Bread, Artisan Ciabbata Baby Loaf, Cibatta Bread, California Sourdough Bread Whole Grain, and California Sourdough Bread products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. §343] and its implementing regulations at 21 CFR Part 101. You may find the Act and FDA’s regulations through links in FDA's home page at www.fda.gov.
Serious deficiencies observed during the inspection included:
Current Good Manufacturing Practices
1. Your firm failed to reject, or if permissible, treat or process to eliminate food which has become contaminated to the extent of being adulterated within the meaning of the act to comply with 21 CFR 110.80. Specifically, an open bag of lard was covered in dirt, dust and debris in the basement storage area.
2. You failed to take necessary precautions to protect against contamination of food and food packaging systems with microorganisms and foreign substances to comply with 21 CFR 110.10(b)(9). Specifically, uncovered dough was stored in the walk-in refrigerator.
3. You failed to use a procedure for cleaning and sanitizing equipment and utensils that provides adequate cleaning and sanitizing treatment to comply with 21 CFR 110.35(d)(5). Specifically, you clean your mixing bowl only by rinsing with water once per day, and you clean the exterior of the mixer once per week. In addition, the mixing bowl was observed with encrusted food residues on both the mixer and on the outside and inside of the mixing bowl.
4. Supervisory personnel are not competent in current good manufacturing practices to assure personnel are in compliance with all requirements to comply with 21 CFR 110.10(d). Specifically, management did not have knowledge on how to clean food contact surfaces and personnel had to be coached on how to use the three compartment sink. Our investigator observed management and personnel preparing sanitizing solution for the three compartment sink by mixing a premixed dispenser of detergent with a premixed dispenser of sanitizing solution into the same compartment. In addition, management and the same personnel were observed preparing sanitizing solution for the last compartment of the three compartment sink by mixing clean water with premixed sanitizing solution, thus diluting the premixed sanitizing solution.
5. You failed to perform chemical testing to identify sanitation failures to comply with 21 CFR 110.80. Specifically, sanitizer used for sanitizing food contact surfaces is not verified for proper concentration.
6. You failed to avoid constituting plumbing as a source of contamination to food, water supplies, equipment, and utensils to comply with 21 CFR 110.37(b)(3). Specifically, our investigator observed the following:
- three compartment sink sprayer hanging below the flood level rim of the sink.
- hose stored in the mop sink without a backflow protection device.
- uncovered sewage ejector pit in the basement, allowing sewer gas, and other chemical and microbial contaminants to emanate from the pit into the food processing and food storage areas.
7. Your employees failed to wash hands thoroughly in an adequate hand-washing facility before starting work to comply with 21 CFR 110.10(b)(3). Specifically, employees rolling dough with their bare hands were observed to not wash their hands prior to starting work.
8. You failed to have sanitary towel service or suitable drying devices at your hand-washing facilities to comply with 21 CFR 110.37(e)(3). Specifically, the hand towel dispensers above the hand sinks in the production room were empty. When our investigator requested something to dry their hands, they were brought a common cloth towel.
9. You failed to provide adequate screening or other protection against pests to comply with 21 CFR 110.20(b)(7). Specifically, our investigator observed a 1” x 3” opening under the outside door in the receiving/shipping area.
10. You failed to store and/or dispose rubbish and any offal to minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, and ground surfaces to comply with 21 CFR 110.37(f). Specifically, your refuse containers were left open in the alley behind the building, and debris was observed alongside the refuse containers.
11. You failed to provide adequate lighting in dressing and locker rooms, and in all areas where food is examined, processed, or stored to comply with 21 CFR 110.20(b)(5). Specifically, our investigator observed inadequate lighting in the walk-in cooler, locker room, and the basement where food is stored and manufactured. The light was inadequate to read labels or discern colors or conditions of utensils and surfaces.
12. You failed to construct floors, walls, and ceilings in such a manner to be adequately cleaned, kept clean, and kept in good repair to comply with 21 CFR 110.20(b)(4). Specifically, the cover for the electrical box in the old bread room was missing and a metal shield was falling off the wall in the bread storage room.
1. Your Bread Crumbs product is misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare the major food allergen, wheat, as required by Section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines 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, as "major food allergens." 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 ingredient, Section 403(w)(1)(A) of the Act, [21 U.S.C. 403(w)(1)(A)], or
- The common or usual name of the food allergen in the list of ingredients is followed in parentheses by the name of the food sources from which the major food allergen is derived [e.g. “(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 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)].
2. Your Bread Crumbs, Focaccia Bread, French Bread, and California Sourdough Bread Whole Grain 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 and each ingredient is not declared on the labels, as required by 21 CFR 101.4. For example:
- Your Bread Crumbs product fails to contain an ingredient statement.
- Your Focaccia Bread label lists tomato as an ingredient. According to the tomato ingredient you use in manufacturing this product, the ingredient contains the following sub-ingredients that are not identified on the Focaccia Bread label: tomatoes, tomato juice, citric acid, and calcium chloride.
- Our investigator observed that (b)(4) (dough conditioner) is an ingredient used to manufacture your French Bread; however, (b)(4) and its sub-ingredients are not listed in the ingredient statement.
- Your California Sourdough Bread Whole Grain label lists assorted grains as an ingredient; however, you fail to declare the sub-ingredients of the assortment of grains.
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)], 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 Focaccia Bread, Bread Crumbs, Artisan Ciabatta Baby Loaf, Ciabatta Bread, California Sourdough Bread Whole Grain, and California Sourdough Bread products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C § 343(q)] because the product labels fail to contain nutrition information as required by 21 CFR 101.9.
Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18) [or see http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm053857.htm] for information on filing for an annual exemption. The application may be submitted online at: https://www.accessdata.fda.gov/scripts/NLE/client/login.cfm. We have no record of your firm having filed a Small Business Nutrition Labeling Exemption Notice.
4. Your Focaccia Bread product is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels do not contain the name of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
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, (b)(3)(B) of the date of this letter. (b)(3)(B) may be accomplished on-line at http://www.access.fda.gov because it will result in an automatic confirmation of (b)(3)(B).. We strongly encourage the use of (b)(3)(B)
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 (b)(3)(B) the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's (b)(3)(B). 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:
5600 Fishers Lane
Rockville, MD 20857
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will (b)(3)(B) using the same method used to submit the (b)(3)(B) to FDA. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
We also have the following comments about your product labels:
- Your Focaccia Bread label declares the net weight without a unit of measure. Statements of weight must be declared in terms of avoirdupois pound and ounce in accordance with 21 CFR 101.105(b)(1).
- The serving size and servings per container for your French Bread are inconsistent. In accordance with 21 CFR 101.9(b)(8), the number of servings per container shall be based on the serving size for the product. Your French Bread product label declares a net weight of “1LB/454g,” a serving size of “2oz (57g/about 3-inch slice) and a servings per container of “12”. Based on a serving size of 57g, your servings per container would be 8.
Further, Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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 actions you are taking to correct these violations. You should include in your response documentation such as copies of your revised labels, related sanitation corrective actions, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case # 417992) when replying. If you have questions about the content of this letter, you may contact Ms. Sexton at 312-596-4225 or by email at firstname.lastname@example.org.
Scott J. MacIntire