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  5. Salt City Baking Company, LLC - 689956 - 11/14/2024
  1. Warning Letters

WARNING LETTER

Salt City Baking Company, LLC MARCS-CMS 689956 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Jedediah B. Fox
Recipient Title
Owner
Salt City Baking Company, LLC

60 E Gordon Avenue
Murray, UT 84107
United States

jed@scbaking.com
Issuing Office:
Human Foods Program

United States

WARNING LETTER

Reference: CMS Case # 689956

Dear Mr. Fox:

The United States Food and Drug Administration (FDA) inspected your manufacturing facility located at 60 E Gordon Avenue, Murray, Utah from July 8, 2024, to July 11, 2024. The inspection revealed significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

Based on FDA’s inspectional findings, we have determined the ready-to-eat (RTE) bread 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 been contaminated with filth or whereby they may have been 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 website at www.fda.gov.

At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing the violations found at your facility. To date, we have not received a response to the FDA 483 describing corrective actions taken by your firm. 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.

Your significant violations are as follows:

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

1. You did not conduct a hazard analysis to identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for your RTE bread products, as required by 21 CFR 117.130(a)(1). Specifically:

a. Your facility’s written hazard analysis, which is not product-specific, did not consider environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it required a preventive control. Your facility manufactures RTE bread products (such as White Cottage sliced bread) which are exposed to the environment after baking and handled by employees 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, contamination with environmental pathogens is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Preventive controls include sanitation controls, which 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, when contamination with environmental pathogens is a hazard requiring a preventive control, you must verify the effectiveness of this preventive control by performing environmental monitoring for an environmental pathogen or for an appropriate indicator organism, by collecting and testing environmental samples (see 21 CFR 117.165(a)(3)). You are not performing environmental monitoring to evaluate the effectiveness of your sanitation practices regarding employee practices and cleanliness of food-contact surfaces.

Furthermore, 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). We note that you did not have adequate controls in place for contamination with environmental pathogens regarding sanitation, monitoring, and verification activities, as evidenced by the following observations during the inspection:

i. On July 9, 2024, an employee was observed drinking from a personal container in the packaging room using their gloved hands to hold the container. The same employee then touched exposed RTE bread without first washing or sanitizing their hands or changing their gloves.

ii. On July 10, 2024, after your firm completed sanitation:
  a. During a pre-production check of your RTE bread slicer, apparent food product residue was observed on food-contact surfaces, including the blades and blade guides.
  b. During a pre-production check of your RTE bun slicer, a buildup of debris on the roller of the bottom conveyor was observed. The roller is in direct contact with the food-contact surface of the conveyor.

We did not observe any corrective actions taken by your firm, and employees were observed using this equipment in manufacturing after the above-mentioned observations.

b. Your facility’s written hazard analysis did not consider mycotoxins as a known or reasonably foreseeable hazard to determine whether it required a preventive control. Your bread products (such as White Cottage sliced bread) contain wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, contamination with mycotoxins is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control (i.e., supply-chain control) in the wheat flour ingredient. 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). At the time of the inspection, you did not have this program in place.

2. Your written allergen preventive controls do not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and for food labeling to ensure the food is not misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(c)(2). Specifically:

a. Your facility’s written hazard analysis determined that “(b)(4)” (i.e., (b)(4)) is a hazard requiring a preventive control. Your facility manufactures a variety of bread products with unique allergens (such as milk, egg, and sesame) on shared food-contact equipment and on the same production day. Your written Preventive Controls document indicates that the hazard of allergen cross-contact will be significantly minimized or prevented through scheduling and segregation practices. However, your allergen preventive control procedures do not cover sesame, nor do they include preventive control management components (monitoring, verification, and corrective action) for any allergens (see 21 CFR 117.140).

b. Your facility’s written hazard analysis determined that “(b)(4)” is a labeling hazard requiring a preventive control. Your facility manufactures a variety of bread products with different allergen profiles (such as wheat, milk, egg, and sesame). A Packaging Line Lead goes to a peg board containing several preprinted labels and selects the label for the product being packaged. The preprinted labels are taken to the packaging line where employees place the label on the side of the cardboard box. Your written Preventive Controls document states “(b)(4)” at the (b)(4) step. However, your procedures do not cover sesame, nor do they include preventive control management components
(monitoring, verification, and corrective actions) for any allergens (see 21 CFR 117.140).

In addition, your bread products are packaged in plastic bags and then the bags are placed into a cardboard case for distribution for use by foodservice establishments. Your finished product labels are applied to the outside of the cardboard case. We note that you did not have adequate controls in place for undeclared allergens regarding monitoring and verification activities (see 21 CFR 117.140(1), (3)). For example, the ingredient list on the product label for Sesame hamburger buns states that the product includes “Sesame Seeds.” Although you chose to include a “Contains” statement on the label, it is incomplete in that sesame is not listed.

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

1. You did not conduct operations under conditions and controls necessary to minimize the potential for growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food, as required by 21 CFR 117.80(c)(2). Specifically:

a. On July 9, 2024, exposed RTE bread was observed cooling next to the oven, and below:
  i. A ceiling vent covered with an accumulation of apparent dust and a long stringy-type material dangling down.
  ii. Flaking paint on a ceiling tile support frame.
  iii. Missing ceiling tiles with exposed insulation hanging down.

b. On July 9, 2024, an apparent black mold-like substance was observed from the floor to ceiling in a corner of the oven cooling area where exposed RTE bread was being cooled.

c. On July 9, 2024, exposed RTE bread was observed cooling beneath ceiling tiles with apparent condensation stains and flaking paint on the ceiling tile grid.

d. On July 9, 2024, exposed Sesame hamburger buns were observed cooling on carts located in the packaging room. A fan was observed blowing air across the packaging room. This may contribute to sesame seeds being transported from the Sesame hamburger buns to products not containing sesame seeds. For example, sesame seeds were observed on trays containing exposed Burly hamburger buns, which do not contain sesame seeds. One of the Burly hamburger buns was observed to have a sesame seed on the top. In addition, sesame seeds were observed on trays containing exposed Sour Charlie bread, which does not contain sesame seeds. An employee at your firm informed our investigator the Burly hamburger buns and Sour Charlie bread found to be contaminated with sesame seeds were disposed of the same day.

e. On July 10, 2024, an employee was observed using an ice bin (post-sanitation) to transfer ice into a mixer to produce the first dough of the production day. After the ice was transferred, an approximately quarter-size piece of apparent dough residue was observed on the inside bottom corner of the bin.

f. On July 10, 2024, a mixer in the production room was observed to have multiple areas with visible apparent dough residue on the inside (food-contact surface) after your sanitation process was complete.

g. On July 10, 2024, the first dough of the day’s production run was observed passing through the dough sheeter, which had apparent dough residue remaining post-sanitation on the metal chain links that are used to form the dough into rolls.

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

a. On July 9, 2024, more than fifty (50) apparent live insects were observed inside an ingredient bin containing dough strengthener, and approximately five (5) apparent live insects were observed inside an ingredient bin labeled “(b)(4)”. An employee disposed of the contents of these two bins the same day. However, on July 10, 2024, the following was observed:

  i. Approximately two (2) apparent live insects in the ingredient bin containing dough strengthener.
  ii. One (1) apparent live insect in the ingredient bin labeled “(b)(4).”
  iii. Three (3) apparent live insects in an ingredient bin containing “High Gluten Flour.”
  iv. Approximately thirteen (13) apparent live insects in an ingredient bin containing Vital Gluten.
  v. Four (4) apparent live insects in an ingredient bin labeled “(b)(4).”
  vi. One (1) apparent live insect in an ingredient bin with “(b)(4)” dough conditioner.

b. On July 9, 2024, apparent insect trails were observed in apparent flour dust on the floor in the production area and on the floor behind ingredient bins storing raw materials/ingredients. On July 10, 2024, apparent insect trails were also observed on the floor under the conveyor for the Koenig line after your sanitation process was complete and before production began.

c. On July 9, 2024, two holes (open to the exterior of the facility) of approximately (b)(4) inches in diameter were observed in the production room wall.

d. On July 10, 2024, a catch pan under the conveyor on the Koenig line was observed to contain apparent dough residue and approximately fifty (50) apparent live insects.

3. You did not ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices by wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR 117.10(b)(6). Specifically, during the inspection, multiple employees were observed not wearing hair restraints. For example, on July 10, 2024, an employee was observed transporting RTE bread from the oven area to the packaging area without a hair restraint. In addition, an employee with facial hair was observed not wearing a facial hair restraint while packaging RTE bread into plastic bags.

The violations cited in this letter are not intended to be an all-inclusive list of 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 that your firm complies with all requirements of federal law, including applicable 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 by the FDA including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

In addition to the violations described above, we offer the following comment:

• We note that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility, and the individual’s assigned duties, as required by 21 CFR 117.4(b)(2). You are required to establish and maintain documentation of this training for each individual, as provided by 21 CFR 117.4(d).

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 fifteen (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.

Please send your reply to the Food and Drug Administration, Attention: Carrie Jolly, Compliance Officer, via email at carrie.jolly@fda.hhs.gov. If you have any questions regarding this letter, you may contact Carrie Jolly, Compliance Officer, via email at carrie.jolly@fda.hhs.gov. Please reference 689956 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Acting Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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