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WARNING LETTER

Breadbox Co. MARCS-CMS 686647 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Mehran Termechi
Recipient Title
Owner & Chief Executive Officer
Breadbox Co.

10603 Painter Ave
Santa Fe Springs, CA 90670
United States

ron.melrosebaking@gmail.com
Issuing Office:
Human Foods Program

United States

November 18, 2024

WARNING LETTER

Re: CMS # 686647

Dear Mr. Termechi,

The United States Food and Drug Administration (FDA) inspected your human food manufacturing facility, located at 10603, Santa Fe Springs, CA, from May 10 through June 7, 2024. During the inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Regulations (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) bakery products manufactured in your facility are adulterated within the meaning 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)]. You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.

At the conclusion of the inspection, FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your facility. To date, FDA has not received a written response to the inspection. After reviewing the inspectional findings, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility.

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

  1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR § 117.126(a)(2). Your food safety plan must also include the following:
    I. The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
    II. The written preventive controls, as required by 21 CFR § 117.135(b);
    III. The written supply-chain program, as required by Subpart G;
    IV. The written recall plan, as required by 21 CFR § 117.139(a);
    V. The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
    VI. The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
    VII. The written verification procedures, as required by 21 CFR § 117.165(b).

Your facility manufactures a variety of RTE bakery products, including but not limited to breads muffins, cookies, croissants, and bagels. However, you did not have a food safety plan with any of the required elements for any of the products manufactured by your facility. For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)). Also, 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 (see 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(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) 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). You must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.160). 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 (see 21 CFR § 117.130(b)(1)(ii)). Your facility manufactures more than 1900 bakery products that contain allergens (such as wheat, soy, milk, eggs, tree nuts (e.g., almonds) and sesame). These products containing different allergen profiles are processed on shared equipment using shared utensils on the same production day. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR § 117.135(c)(2)).

You do not have controls in place for the hazard of allergen cross-contact, as evidenced by the following:

i. On May 15, 2024, sesame seeds were observed embedded on the surfaces of breadsticks in at least two bags of Breadman Breadsticks (15 oz - finished product produced on May 14, 2024). The Breadman Breadsticks do not include sesame seeds as ingredients. Furthermore, on May 23, 2024, sesame seeds were observed embedded on the surfaces of breadsticks in at least two bags (unlabeled, bulk order, finished product) of breadsticks, where the ingredients do not include sesame seeds.

ii. On May 10, 2024, one of your production employees was observed using a mixer to make dough for Brioche (which contains wheat, egg, and unsalted 70% vegetable oil spread (soy lecithin, milk)). After the (b)(4) step, the production employee cleaned the mixer by scraping the excess dough from the interior of the mixer bowl and wiping it with a wet fabric cloth. Yellow, egg-like food residue, from the Brioche dough, remained on the interior of the mixer bowl. The same mixer bowl was then used to make dough for the Torpedo product which does not contain the soy or egg allergen ingredients.

b. For your RTE bakery products, you did not identify and evaluate undeclared color additives as a reasonably foreseeable hazard to determine whether they are a hazard requiring a preventive control (see 21 CFR § 117.130(b)(1)(ii)). Your facility manufactures products containing the color additive FD&C Yellow #5. FD&C Yellow #5 is known to cause adverse reactions in sensitive individuals, including bronchial asthma in asthmatic individuals. Therefore, undeclared FD&C Yellow #5 is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify undeclared FD&C Yellow #5 as a hazard requiring a preventive control. Preventive controls include procedures, practices, and processes necessary to ensure that food manufactured processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) (see 21 CFR 117.135(a)(1) and 21 CFR 117.135(c)(6)), such as during receipt of labels and during packaging/labeling operations, to ensure FD&C Yellow #5 is declared for products containing this color additive. You do not have controls in place, as evidenced by the following:

i. On May 14, 2024, your facility manufactured Breadman Raisin Bread, which contains butter essence (FD&C Yellow #5) and egg shade liquid color (FD&C Yellow #5). However, the finished product label, which you distributed on May 15, 2024, did not declare FD&C Yellow #5 on the ingredients list. You recalled this product on May 16, 2024.

ii. On May 14, 2024, your facility manufactured Brioche, which contains butter essence (FD&C Yellow #5) and egg shade liquid color (FD&C Yellow #5) and distributed them to your bulk-order customers (i.e., restaurants, hotels, etc.). However, the Ingredient & Allergen Statement that you sent to your bulk-order customers did not declare FD&C Yellow #5. Additionally, you do not include the Ingredient & Allergen Statement with every delivery of bulk orders to customers. The customer only receives the statement with the initial bulk order. You distributed the Brioche on May 15, 2024 and later recalled it on May 16, 2024.

c. For your RTE bakery products, you did not identify and evaluate recontamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii). Your facility manufactures RTE bakery products which are exposed to the environment after they exit the oven, such as while they are cooled prior to packaging. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Therefore, recontamination with environmental pathogens is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR § 117.135(c)(3)). In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)). You do not have controls in place for contamination with environmental pathogens, as evidenced by the following:

i. On May 14, 2024 and May 15, 2024, loaves of RTE bread were observed stored directly on metal racks with heavily encrusted grease and debris build-up, to be packaged and distributed to customers. These racks were in the RTE packaging area.

ii. On May 23, 2024, loaves of RTE whole wheat bread and RTE squaw bread were observed cooling directly on the same dirty metal racks in the baking room.

iii. On May 14, 2024, a production employee was observed removing loaves of RTE squaw bread from metal pans and placing them on a metal rack in the baking room using a pair of soiled fabric mittens. The soiled fabric mittens touched the loaves of RTE squaw bread. These same mittens were also used to handle oven doors and metal carts after baking. Additionally, on May 23, 2024, another production employee was observed removing loaves of RTE wholewheat bread from metal pans and placing them on a metal rack in the baking room using a pair of soiled fabric mittens. The soiled fabric mittens touched the loaves of RTE whole wheat bread.

iv. Your facility does not have an environmental monitoring program to monitor for environmental pathogens.

d. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control (see 21 CFR § 117.130(b)(1)(ii)). Your facility manufactures RTE bakery products that contain wheat flour and tree nuts (e.g., almonds). These ingredients have been associated with mycotoxins. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in these ingredients. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR § 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR § 117.410). You do not have this program in place.

e. For your RTE bakery products, you did not establish a written recall plan. Your RTE bakery products have multiple known or reasonably foreseeable hazards requiring preventive controls (see 21 CFR § 117.139(a). On May 16, 2024 your facility initiated a recall of your Breadman Raisin Bread, Jalapeno Cheese Bagels and Breadman Brioche products due to the lack of proper allergen declarations and the food coloring ingredient FD&C Yellow #5 on finished product labeling.

Current Good Manufacturing Practices Requirements (21 CFR Part 117, Subpart B)

2. Your equipment and utensils used in manufacturing, processing, packing or holding food are not designed and of such material and workmanship as to be adequately cleanable, and are not adequately maintained to protect against allergen cross-contact and contamination, as required per 21 CFR § 117.40(a)(1). Specifically, on May 14, 2024:

a. Employees were observed using wooden baskets to hold dough for sourdough bread. The wooden baskets were splintered, damaged, and repaired with metal nails.

b. The wooden table in the baking room was observed damaged with deep grooves and encrusted food debris build-up on the top surface. Furthermore, metal nails and screws were observed protruding from its surface. An employee placed trays of dough on this table to cut the dough.

c. A thick fabric liner was observed in use in the Oliver dough rolling equipment and both the Oliver dough rolling equipment and fabric liner were observed with encrusted food debris build-up.

d. A rubber tire and nylon fabric straps were used to secure the Benier mixer and Kemper mixer from shaking during operation. Heavy debris and flour were observed accumulating on the tire and straps.

We note that the above-mentioned observations are repeat observations from the California Department of Public Health inspection on April 12, 2017, and from the FDA inspection conducted June 2, 2021 through June 4, 2021.

3. You did not clean and sanitize food-contact surfaces of equipment and utensils as frequently as necessary to protect against contamination of food and against allergen cross-contact, as required per 21 CFR § 117.35(d). Specifically:

a. On May 23, 2024, food residue build-up was observed on your bagel-forming equipment. During production, the dough was observed making direct contact with the residue build-up on the equipment.

b. On May 14, 2024, dark slime-like residue was observed on the interior surfaces of your ice machine. Ice from this machine was observed being used as an ingredient in your bakery products, such as the sourdough bread and the ciabatta bread.

4. Your plant is not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair, as required per 21 CFR § 117.20(b)(4). Specifically:

a. On May 15, 2024, the ceiling inside the proofer room was damaged with metal rust observed on the exterior surface. Carts of exposed dough were observed directly beneath the ceiling in the proofer with steam circulating throughout the room while the proofer was in use.

b. On May 15, 2024, standing water was observed on the floor in the dough production room which serves as a harborage condition for the growth of pathogenic bacteria. During production, the wheels of metal dough carts were observed being rolled through the standing water in the dough production room to the proofer and then to the baking room to be placed into the ovens for baking. Exposed RTE bakery products were held in the baking room for cooling.

c. On May 15, 2024, dirt and debris accumulation was observed on the pitted floor in the RTE packaging area. Exposed RTE bakery products were observed being packaged for distribution to customers in this area.

5. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas to protect against the contamination of food on the premises by pests, as required per 21 CFR § 117.35(c). Specifically:

a. On May 14, 2024, a flying insect was observed inside the ciabatta dough mixer in the dough production room, while the mixer was being used for production.

b. On May 14, 2024, two flying insects landed on separate pieces of dough which were to be made into jalapeno cheese toasts. The pieces of dough were placed on the wooden dough table in the dough production room.

c. On May 10, 2024, a flying insect was observed in the dough production room near the dry ingredient weighing area and the wooden dough table during production.

d. On May 14, 2024, gaps greater than (b)(4) underneath the metal roll-up door of the dry-storage warehouse were observed which may serve as entry points for rodents.

We note, the above-mentioned observations are repeat observations from the inspection conducted on June 2, 2021 through June 4, 2021.

6. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required per 21 CFR 117.35(a). Specifically:

a. On May 14, 2024, damaged and missing cove base tiles were observed along the walls in the dough production room as well as the baking room which resulted in exposed holes and cracks in the walls. Debris was observed accumulating along the wall with the missing cove base tiles, which is located adjacent to the cooling tunnel exit in the baking room. The exposed holes and cracks in the walls create an uncleanable niche environment which may serve as a harborage area for the growth of pathogenic bacteria.

We note that the above-mentioned observation is a repeat observation from the inspection conducted on June 2, 2021 through June 4, 2021.

b. On May 14, 2024, an accumulation of apparent flour dust was observed in the production room environment on non-operating equipment fixed to the ceiling such as hoppers. Exposed bread dough was observed being manipulated directly beneath this equipment.

7. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms and contamination of food, as required per 21 CFR § 117.80(c)(2). Specifically, on May 14, 2024 and May 15, 2024, exposed loaves of RTE bread were observed cooling inside your cooling tunnel where debris and dust accumulation were observed on the air vents in the cooling tunnel. The moving air passes through the air vents and directly onto the RTE bread.

We note that the above-mentioned observation is a repeat observation from the California Department of Public Health inspection on April 12, 2017, and from the FDA inspection conducted on June 2, 2021 through June 4, 2021.

8. Your plumbing was not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant, as required per 21 CFR § 117.37(b)(2). Specifically:

a. On May 14, 2024, the sink drain was leaking which resulted in drain water leaking directly onto the floor in the production room.

b. On May 14, 2024, the drain line for the ice machine was observed placed inside the floor drain without an air gap between the drain line and floor drain. Employees use ice from the ice machine for the production of your bakery products.

9. You did not take reasonable measures and precautions to ensure that 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). Specifically, on May 14, 2024, a personal leather bag and an open soda can were stored on a stainless-steel table with bags of bread in the RTE packaging area.

We note that the above-mentioned observation is a repeat observation from the FDA inspection conducted September 27, through September 28, 2011, the inspection conducted by California Department of Public Health on April 30, 2014 through May 1, 2014, and the FDA inspections conducted June 2, 2021 through June 4, 2021.

This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Daniel Johnson, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Daniel Johnson via email at: Daniel.Johnson@fda.hhs.gov Please include reference CMS #668646 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, J.D., M.B.A  
Acting Director, Office of Enforcement  
Office of Compliance and Enforcement  
Human Foods Program

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