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  1. Warning Letters

WARNING LETTER

Bread and Cie Wholesale, LLC MARCS-CMS 603969 —


Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages

Recipient:
Recipient Name
Charles D. Kaufman
Recipient Title
President/Owner
Bread and Cie Wholesale, LLC

4901 Pacific Hwy
San Diego, CA 92110-4005
United States

Issuing Office:
Office of Human and Animal Food Division 5 West

United States


Dear Mr. Kaufman:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bakery manufacturing facility located at 4901 Pacific Hwy, San Diego, CA 92110 from December 19, 2019, through January 3, 2020. During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 [21 CFR Part 117]. At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations, listing the deviations found at your firm. Based on FDA’s inspectional findings, we determined that your food products manufactured in your facility 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 were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). You may find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.

We received your written response dated January 27, 2020, describing corrective actions taken and planned by your firm. After reviewing the inspectional findings and responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

1. You did not conduct a hazard analysis for any of your products to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured or processed at your facility and determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically,

a. You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Your facility manufactures various bakery products with different allergen profiles on the same day and on shared equipment.

b. You did not identify and evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, as a known or reasonably foreseeable hazard to determine whether environmental pathogens are a hazard requiring a preventive control. Your facility manufactures RTE food which is exposed to the environment after baking and prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen or control by the supply chain or downstream customer) that would significantly minimize the pathogen.

c. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether mycotoxins are a hazard requiring a preventive control. Your facility manufactures products with wheat flour, raisins, and walnuts, ingredients that have been associated with mycotoxins.

d. You did not identify and evaluate vegetative pathogens, such as pathogenic Escherichia coli and/or Salmonella, as a known or reasonably foreseeable hazard to determine whether vegetative pathogens are a hazard requiring a preventive control. Your facility manufactures various products with wheat flour and/or tree nuts (such as walnuts). These ingredients have been associated with pathogens.

2. You did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under Section 402 of the Act or misbranded under Section 403(w) of the Act [21 CFR § 117.135(a)(1)]. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).

3. You did not prepare, or have prepared, and did not implement a food safety plan for the food manufactured in your facility, such as RTE breads, as required by 21 CFR § 117.126. A food safety plan must include the following:

a. The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
b. The written preventive controls, as required by 21 CFR § 117.135(b);
c. The written supply-chain program, as required by subpart G;
d. The written recall plan, as required by 21 CFR § 117.139(a);
e. The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
f. The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
g. The written verification procedures, as required by 21 CFR § 117.165(b).

We acknowledge you have successfully completed the FSPCA Preventive Controls for Human Food Course. Your response states that you are in the process of drafting a comprehensive written Food Safety Plan. You provided documentation that you are working towards the development of your plan, but you have not submitted your plan. We will assess the adequacy and implementation of your Food Safety Plan during the next FDA inspection.

Current Good Manufacturing Practice (Subpart B):

4. You did not clean your utensils and food contact surfaces of equipment as frequently as necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR § 117.35(d). Specifically, during our inspection our investigator observed the following:

a. Employees were making bread doughs with different allergen profiles in the same mixing bowls without cleaning the bowls in between the different products. Specifically, pretzel dough containing wheat but not milk was mixed immediately after potato dough containing wheat and milk, and residual potato dough was visible in the bowl during the manufacturing of the pretzel dough. In addition, raisin dough containing wheat, milk, and egg but not walnut was mixed immediately after walnut raisin dough containing wheat and walnut, and residual walnut raisin dough was visible in the mixing bowl during the manufacture of the raisin bread.

b. Employees were using a small (b)(4) dough slicer to cut and move bread dough without cleaning the equipment during the production of various bakery products with different allergen profiles. Specifically, onion dough containing wheat but not walnut was made immediately after walnut scallion dough containing wheat and walnut. In addition, residue of pumpkin cranberry dough, which contains wheat, milk, egg, and walnut, was on the equipment during the cutting of walnut raisin dough, which contains wheat and walnuts but not milk and egg. Further, pieces of pumpkin cranberry dough were on the walnut raisin dough.

c. Employees were using a large (b)(4) dough slicer to stretch, cut, and move dough and were only dry cleaning the equipment via air compressor and scraping between bakery products with different allergen profiles. Specifically, sourdough pullman bread dough containing wheat and milk but no eggs was made after challah dough containing wheat, milk, and eggs with only a dry clean performed between the two products, and there was residual dough on the conveyor belt after dry cleaning. Also, there was residual flour on the conveyor belt, and dough on the rollers, blades, and metal chain after the manufacture of jalapeno cheese dough containing wheat and milk and right before the manufacture of Levain bread containing only wheat.

d. The (b)(4) table used for dough shaping was not cleaned between products. Specifically, rosemary dough containing wheat but not walnut was placed on the (b)(4) table immediately after the walnut raisin dough containing wheat and walnut.

e. Employees were using the (b)(4) inch slicer in the packaging area to slice multigrain bread containing only wheat after slicing brioche bread containing wheat, milk, and egg. The only cleaning performed between the slicing of the two different products was dry cleaning with an air compressor. Furthermore, the use of compressed air creates a risk of allergen cross-contact because it tends to blow allergens from one location in the facility to another.

Your written response outlines the corrective actions you plan and have implemented, including modifying your production schedule to limit allergen cross-contact between distinct products by manufacturing products with the least allergens first, whenever practical. You indicate that you have implemented new cleaning procedures for equipment used such as cleaning mixers, mixing bowls, and a wood table with soap and water. You also indicate that you have restricted similar allergen profile mixes to specific bowls and/or mixing machine/bowl combinations and that you have also restricted certain allergen profiles on your small and large (b)(4) machines. However, you did not provide copies of your updated procedures, including your updated cleaning procedures, records associated with their implementation and verification, nor your updated processing schedule. We will verify the adequacy of these corrective actions during our next inspection.

5. You did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR § 117.10(b). During our inspection, our investigator observed the following conditions which can result in the recontamination of the RTE food with environmental pathogens:

a. Employees used an open trash can lid to hold trays of RTE hamburger buns at the bun packing line.

b. Employees touched the trash cans with gloved hands and then touched RTE hamburger buns without changing gloves.

c. An employee touched their protective hair covering and outer garments with gloved hands and then touched RTE bread.

d. Employees were slicing and pushing RTE breads into (b)(4) bags with their bare hands.

e. Fans covered in debris and grease were used to cool RTE bread.

f. The (b)(4) station in your packaging area, where RTE bread products are packaged, did not have any available sanitizer.

Your response states (b)(4). Your response also states (b)(4). Your response states (b)(4). However, your response does not describe how you will prevent this employee practice in the future, nor did you provide the training records that reflect the completion of their training. Your written response also states (b)(4).

We acknowledge that during the inspection, you voluntarily cleaned your fans of grease and debris. However, you have not provided any details on how you plan to monitor and keep these fans in sanitary condition. We will verify the adequacy of these corrective actions during our next inspection.

6. You did not ensure that all employees are qualified to perform their assigned duties, as required by 21 CFR § 117.4(a) and did not document that employees received training in the principle of food hygiene and food safety, including the importance of employee health and personal hygiene, as required by 21 CFR § 117.4(d).

Your response states (b)(4) and this training documented in compliance with 21 CFR part 117. However, your response did not include the completed records documenting your employee training. We will verify the adequacy of these corrective actions during our next inspection.

MISBRANDING VIOLATIONS

Your response states (b)(4). Further, you state (b)(4). As noted below, these measures are insufficient to bring your products into compliance.

1. Your Walnut Raisin bread and other wholesale bakery breads, rolls, buns, ciabatta, focaccia, and flatbread products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to accurately declare major food allergens, as required by section 403(w)(1) of the Act. Specifically, your products are distributed for wholesale distribution in paper bags. The paper bags contain hand written delivery name and date information. No additional labeling is present. Your products can contain the following allergens: wheat, egg, milk, and tree nuts (for example, walnuts).

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 that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded under section 403(w) of the Act 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., “Whey (Milk)”), 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)].

2. Your Walnut Raisin bread and other wholesale bakery breads, rolls, buns, ciabatta, focaccia, and flatbread products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food, as required by 21 CFR 101.3. Specifically, your products are not packaged with any labeling other than the delivery name and date.

3. Your Walnut Raisin bread and other wholesale bakery breads, rolls, buns, ciabatta, focaccia, and flatbread products are misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because their labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Specifically, your products are not packaged with any labeling other than the delivery name and date.

4. Your Walnut Raisin bread and other wholesale bakery breads, rolls, buns, ciabatta, focaccia, and flatbread products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). Specifically, your products are not packaged with any labeling other than the delivery name and date. Further, your Jalapeno & Cheese and Sourdough “market” packed bread products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the products are labeled with the firm name and address of Bread and Cie Bakery/Café. As this is not the manufacturer of the product, the name and address must be modified to reflect the connection between the product and the firm, such as “distributed by” or “manufactured for” or changed to reflect the Bread and Cie Wholesale, LLC name and address to be in compliance with 21 CFR 101.5(c).

5. Your Jalapeno & Cheese and Sourdough “market” packed bread products, and your Walnut Raisin bread and other wholesale bakery breads, rolls, buns, ciabatta, focaccia, and flatbread products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example:

• Your Jalapeno & Cheese “market” packed bread does not list the sub-ingredients of the “white starter” or Cheddar cheese. These ingredients themselves are made of multiple ingredients and those ingredients must be declared. Further, “white starter” and “filtered water” are not the common or usual names for these ingredients.

• Your Sourdough “market” packed bread does not list the sub-ingredients of the “white starter” ingredient. This ingredient is itself made of multiple ingredients and those ingredients must be declared. The ingredient “Unbleached white flour” appears to be enriched and therefore, “Unbleached white flour” is not the common or usual name of the ingredient. Further, “white starter” and “filtered water” are not the common or usual names for these ingredients. Finally, we note a discrepancy between the ingredient list on the package label and the ingredient list on the “Bread & Cie Wholesale Bread Product Ingredient List” related to the starter.

• Your Walnut Raisin bread and other wholesale bakery breads, rolls, buns, ciabatta, focaccia, and flatbread products are not packaged with any labeling other than the delivery name and date.

Regarding your Jalapeno & Cheese and Sourdough “market” packed bread products and according to 21 CFR 101.4(b)(2), 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. We recommend you review the entirety of 21 CFR 101.4(b) when evaluating how to meet the requirements for your non-“market” packed bread products.

6. Your Jalapeno & Cheese and Sourdough “market” packed bread products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear a nutrient content claim, but the products do not meet the requirements to make such claim.

Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient on the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically:

Your Jalapeno & Cheese and Sourdough “market” packed bread products include the nutrient content claim “most contain no fat;” however, neither of these products meet the requirements in 21 CFR 101.62(b)(1)(i) for a “no fat” claim of less than 0.5 grams of fat per RACC and per labeled serving. According to the nutrition labels, the Jalapeno & Cheese product contains 3 grams of fat per serving and the Sourdough product contains 0.5 grams of fat per serving.

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable requirements. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction.

In addition, we also offer the following comments regarding the labeling of your products:

• On the Jalapeno & Cheese and Sourdough “market” products, the recommended serving size label statement for unsliced bread is “2 oz (56 g/_inch slice)”, not “1/8 loaf.” [21 CFR §101.12(b), Table 2]

• As you may already know, FDA finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements. Manufacturers must revise labels to meet the new requirements. For more information on the new requirements, please see https://www.fda.gov/food/food-labeling-nutrition/changes-nutrition-facts-label.

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 reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, 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 respond in writing within fifteen (15) working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again. In your response, you should include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections before you respond, you should state the reason for the delay and include a timetable for implementation of those corrections.

Your written response should be directed to:

Sergio Chavez
Director Compliance Branch
Food & Drug Administration
HAF Division West 5
19701 Fairchild
Irvine, CA 92612

Refer to the Unique Identification Number (CMS 603969) when replying.

If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@fda.hhs.gov , or (949) 608-4496.


Sincerely,
/S/
Darla R. Bracy, District Director
Office of Human and Animal Food
Division 5 West

 

 
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