- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameMr. Magdiel F. Cuellar-Perez
- The Bonami Baking Company, Inc.
380 E 10th St
Pittsburg, CA 94565
- Issuing Office:
- Division of Human and Animal Food Operations West V
Dear Mr. Cuellar-Perez:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 380 E 10th St, Pittsburg, CA 94565 on April 4-22, 2022. 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 a Form FDA 483, Inspectional Observations, listing the deviations found at your firm. 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 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 http://www.fda.gov/.
On May 5, 2022, FDA received your written response, describing corrective actions taken and planned by your firm. After reviewing the inspectional findings and response 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. We also address your response below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR part 117, Subpart C):
1. You did not prepare, or have prepared, and implement a food safety plan, as required by21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by oneor more preventive controls qualified individuals (PCQIs), as required by 21 CFR §117.126(a)(2). Your food safety plan must also include the following:
1) The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
2) The written preventive controls, as required by 21 CFR § 117.135(b);
3) The written supply-chain program, as required by Subpart G;
4) The written recall plan, as required by 21 CFR § 117.139(a);
5) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
6) The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
7) The written verification procedures, as required by 21 CFR § 117.165(b).
However, you did not have a food safety plan with any of the required elements. 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. Your facility manufactures at least 370 various bakery products that contain allergens(such as wheat, eggs, milk, and tree nuts); products containing different allergen profiles are processed on shared equipment and 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 allergen cross-contact, as evidenced by the following observations of employee practices and equipment cleaning:
i. On April 20, 2022, after your employees made hamburger bun dough (containing wheat, egg, and milk) in the medium sized mixer, they performed cleaning. The cleaning consisted of using a brush and scraper to remove flour and debris, and then employees were observed using towels from a bucket of water that did not contain detergent to wipe the tables and the inside of the medium mixer. This procedure does not involve cleaning with detergent; therefore, you do not ensure the control of allergen cross-contact between products that contain different allergenic ingredients. After cleaning, our Investigator observed hamburger bun dough debris on the upper lid and paddle inside of the mixer and within cracks of the wooden table. Thereafter, employees proceeded to add ingredients for bagel dough (containing only wheat allergen) in the medium sized mixer.
ii. On April 20, 2022, food debris buildup was observed on knives, scales, bins containing ingredients, scoopers, and scrapers located in the bread production room. These items were observed being used repeatedly throughout production for products containing different allergens without appropriately cleaning and sanitizing between products. For example, knives used to cut hamburger bun dough (containing wheat, egg, and milk) were rinsed in the hand washing sink and then used to cut bagel dough (containing wheat allergen only) without appropriately cleaning and sanitizing the knives.
b. For your RTE bakery products, you did not identify and evaluate contamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it is 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 and sliced 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. 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)).
c. You did not identify and evaluate bacterial pathogens, such as pathogenic Escherichia coli and Salmonella, as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures RTE bakery products made from wheat flour, such as RTE whole wheat sour dough bread, wheat hamburger buns, whole wheat bagels, whole grain croissants containing wheat, and blueberry muffins containing wheat. Wheat has been associated with vegetative bacterial pathogens such as pathogenic Escherichia coli and Salmonella. A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial pathogens as a hazard requiring a preventive control. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing. Process controls must also include the parameters associated with the control of the hazard and the minimum and maximum values needed to significantly control the hazards (see 21 CFR § 117.135(c)(1)). These controls must be validated as required by 21 CFR § 117.160. You were not able to provide validation studies during the inspection to show that the oven bake times and temperatures were sufficient to appropriately destroy pathogens, and you have not conducted accuracy checks that show the thermometers and timers of your ovens were appropriately calibrated as required by 21 CFR § 117.165(a)(1)).
d. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures RTE bakery products that contain wheat flour and tree nuts (e.g., walnuts, pecans, and 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.
Your response provided corrective actions you plan to take, including that you would be conducting a hazard analysis, asking your supplier to provide specifications and explain how they prevent mycotoxins, following the sanitation process procedures stated in your document titled, “Sanitation Process,” sending an employee to take a Food Safety Preventative Controls Alliance course, and creating a recall plan. You also stated that you have established a system to avoid cross-contact. You submitted a recall plan and a document titled, “Sanitation Process.” You also submitted a document titled, “The Bonami Baking Company HACCP Plan.” However, your plan does not include all of the necessary elements of a food safety plan as required by 21 CFR § 117.126(b). For example, it does not include a hazard analysis and preventive controls. Further, we cannot fully evaluate your response because the document titled, “Sanitation Process” does not include details as to what utensils/equipment will be cleaned using this procedure, which detergent and sanitizer will be used, how often the equipment will be cleaned, who will conduct cleaning, corrective actions, and how you will verify adequate cleaning. Additionally, you stated, “We have established a system to our utensils with specifics used to each depending on what we are manufacturing, so we can avoid the cross-contact.” However, you did not submit any additional information to shed light on what your new system for utensils entails. Also, you submitted a document titled, “Allergy and Sensitivity Information,” which includes a non-comprehensive list of products you manufacture, and their associated allergens. However, you did not indicate the purpose of this document, and it is unclear whether this is an internal document, or something that is provided to customers. Lastly, you stated you will have completed an FSPCA Preventive Control course by the beginning of June, at which point you will have a PCQI on-site to “guide the employees.” We note that your response did not address the other known or reasonably foreseeable hazards such as contamination with environmental pathogens, and bacterial pathogens (i.e., pathogenic Escherichia coli and Salmonella) in your ingredients.
Current Good Manufacturing Practice (21 CFR part 117, Subpart B):
1. 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 by 21 CFR § 117.35(a). Specifically, on April 6, 2022, our Investigator observed the following:
a. Plastic strip curtains at receiving were torn and cracked, with a buildup of black and sticky debris. Employees were observed moving rolling racks, used for processing, in and out of the facility while making contact with the strip curtains.
b. The floor drain of the hand washing sink in the Croissant Room was overflowing onto the production floor.
c. Floors throughout the facility were pitted and cracked, making it difficult to clean and sanitize them.
In addition, you did not clean and sanitize your utensils or equipment in a manner that protects against allergen cross-contact and contamination, as required by 21 CFR § 117.35(a). Specifically, on April 11, 2022, equipment, including rolling racks and plastic crates, were observed being cleaned with a high-pressure spray washer using (b)(4), which is not labeled for use on food-contact equipment, but rather machinery, engine parts, and shop floors. The equipment was then dried using a leaf blower outside of your facility, next to your dumpster. While your employees were cleaning plastic trays, water from the high-pressure spray washer was observed splashing on the concrete foundation and dumpster, and then ricocheting onto surrounding rolling racks and equipment that had been previously cleaned. After cleaning, the equipment is stored outside, and brought into the facility when needed to process RTE bakery products.
In your response, you included a written proposal from Industrial Coating Concepts in Los Angeles, CA, dated May 4, 2022, to do work on your flooring throughout various areas of the facility. We cannot fully evaluate your response because you did not include information indicating whether the contract was finalized, or if or when the floor repairs would be completed. Moreover, you did not indicate how you will continue to maintain your plant in a clean and sanitary condition, and in good repair, moving forward. As noted previously, your document titled, “Sanitation Process” does not include details as to what utensils/equipment will be cleaned using this procedure, which detergent and sanitizer will be used, how often the equipment will be cleaned, who will conduct cleaning, corrective actions, and how you will verify adequate cleaning.
2. You did not take effective measures to exclude pests from your food plant to protect against contamination of food, as required by 21 CFR § 117.35(c). Specifically, on April 4 and 6, 2022, our Investigator observed the following:
a. Rodent excreta pellets (REPs) on 2 opened bags of macaroon mix. One bag had at least 15 REPs and a rodent gnawed hole approximately 2” x 3” at the base of the bag. The other bag had at least 10 REPs and apparent staining. Rodent urine stains, 1 REP, and rodent rub marks were observed on a bag of chopped rosemary.
b. Two (2) REPs on the exiting conveyor of a hamburger bun production machine, and at least 75 REPs and debris in a collection tray at the base of this machine that was located at the northeast end of the Bread Room.
c. At least 10 REPs in the floor drain below the hand washing sink located at the east wall of the Bread Room.
d. Two (2) apparent REPs on a pallet of bags containing (b)(4) brand (b)(4) flour (lot #(b)(4)) that was stored outside of your facility near the rollup door at the south end of your firm.
e. At least 30 live ants on bags of sugar stored in the Bread Room. In addition, at least 50 live ants, as well as ant bait stations, were observed under two ovens on the south wall in the Bake Room. At least 10 live ants were observed southwest end of the roll up door at receiving.
f. An approximate 3”x 28” gap under the receiving roll door south of the Bake Room/Receiving area. In addition, on April 6 and 11, 2022, this door was left open during times when products and equipment were not moving in and out of the facility.
g. A hole, approximately 4” in diameter and partially covered with gray tape, and a crack approximately 1/2” x 1/4” in diameter in the window of the north wall of the bread production room. Additionally, a hole approximately 12” x 6” was observed in the ceiling around the ducting of the HVAC system at the entrance of the Bread Room.
The above-mentioned observations are repeat observations from the California Department of Public Health inspection on April 9, 2018.
You stated in your response that you are “covering and securing every orifice that is open to prevent any rodent to come in at our production site.” In addition, you stated you have a Food Safety Pest Management Logbook, and you have acted on the recommendations made by your pest control company. You stated you conducted a “deep sanitation process and trashed all contaminated product.” You stated that the equipment that was in your facility was taken outside and sanitized completely. We cannot fully evaluate your response because you did not submit any pest control records, photographs, or any other evidence to indicate that the live insects and other pests, and all gaps exposing the interior of the facility to the exterior of the facility, were addressed and/or eliminated. We will verify the implementation and adequacy of these corrective actions during the next FDA inspection.
3. Your equipment and utensils were not designed and were not of such material and workmanship to be adequately cleanable, and must be adequately maintained to protect against allergen cross-contact or contamination, as required by 21 CFR § 117.40(a)(1).Specifically, on April 6, 2022, our Investigator observed the following:
a. Green plastic bowls used to store bread dough were scratched and frayed. In addition, fragments of green plastic from these bowls were sloughing off and found embedded in the bread dough inside the bowl.
b. The conveyor belt of the bagel forming machine was discolored and had a buildup of food debris embedded in the grooves of the conveyor, including sesame seeds and dried cranberries from previous batches of processed bagel dough. Further, the framing of the conveyor belt had a buildup of dust, dirt, and food debris. In addition, formed wheat bagel dough was observed containing food debris (i.e., sesame seeds) from the conveyor belt.
c. Cloth-type fabric on the dough rolling machine for bread products was torn and frayed and had a buildup of food debris from previous batches of processed products.
d. Prep tables used for kneading, cutting, and portioning dough products, including products containing allergenic ingredients, were made of wood that had multiple cracks and nicks, making them difficult to clean and sanitize. In addition, the Investigator observed residual dough product from previous batches of processed products which had accumulated in the cracks and nicks in the table.
e. Stacks of bake pans and trays, and rolling carts for trays were stored outside ofyour facility and exposed to the outside elements. These utensils are brought into your facility when needed for processing dough and baked products.
You stated in your response that you “cleaned and adequately maintained” equipment, replaced equipment, and implemented the procedures stated in your document titled, “Sanitation Process.” Additionally, you contacted your supplier of the belt to replace the cloth-type fabric and are installing tables with a “poly top” that’s easy to clean. You enclosed the area of your facility where the bake pans, trays, and rolling carts are stored so that they would no longer be exposed to the outside. We cannot fully evaluate your response because you did not indicate what corrective action you took in regard to the marred and frayed green plastic bowls. In addition, you did not indicate how you will prevent the same issues with equipment and utensils from recurring in the future. We will verify the implementation and adequacy of these corrective actions during the next FDA inspection.
1. Your Whole Wheat Bagel and Pizza Sheets products are misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] of the Act. Specifically:
a. Your Whole Wheat Bagels are fabricated from two or more ingredients, but the labels fail to bear the common or usual name of each ingredient in the product as required by 21 CFR § 101.4(a)(1). Your Whole Wheat Bagel lacks a list of ingredients.
b. Your Pizza Sheets are fabricated from two or more ingredients, and each ingredient is not declared on the label, as required by 21 CFR § 101.4(b)(2).Specifically, the ingredient “Italian Seasoning,” is a multi-ingredient component and the sub-ingredients are not declared on the label.
c. Your Pizza Sheets ingredient statement fails to declare the specific source of oil in accordance with 21 CFR § 101.4(b)(14).
2. Your Whole Grain Croissant, Whole Wheat Bagel, and Pizza Sheets products are misbranded within the meaning of section 403(e)(2) [21 U.S.C. §343(e)(2)] of the Act because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR § 101.7.
3. Your Whole Grain Croissant, Whole Wheat Bagel, and Pizza Sheets products are misbranded within the meaning of Section 403(e)(1) [21 U.S.C. § 343(e)(1)] in that the packages do not bear labels that list the name and/or place of business of the manufacturer, packer, or distributor in accordance with 21 CFR § 101.5.
This letter is not intended to be an all-inclusive statement of violations that may exist 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 that 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 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 do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent electronically to: email@example.com.
Otherwise, a hardcopy response can be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Food Operations West - Division 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number, CMS 633746, when replying. If you have questions regarding this letter, please contact Clarice J. Ahn, Compliance Officer at firstname.lastname@example.org, or 510-337-6854.
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations West - Division 5