FDA warns bakery for food safety violations, including sanitation and allergen control failures

As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Salt City Baking Company LLC
Murray, UT

The FDA has issued a warning letter to Salt City Baking Company LLC, citing significant violations of federal food safety regulations. The letter, dated Nov. 14, 2024, follows an inspection conducted from July 8 to July 11, 2024, at the company’s facility in Murray, UT.

The inspection revealed severe noncompliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule). At the conclusion of the inspection, FDA investigators issued a Form 483, Inspectional Observations, detailing the deficiencies observed.

Key violations:

Failure to conduct hazard analysis

Salt City Baking failed to perform a hazard analysis for its ready-to-eat (RTE) bread products, including White Cottage sliced bread. Specifically:

• Environmental pathogens: The company did not address the risk of contamination with pathogens such as Salmonella, which could occur during post-baking handling or packaging. The facility lacked environmental monitoring, sanitation controls, and preventive control management practices to minimize such hazards.
• Mycotoxins in wheat flour: The company did not implement a supply-chain program to manage the risk of mycotoxins, such as deoxynivalenol (DON), in wheat flour, a known hazard requiring preventive controls.

Allergen control failures

The company failed to establish adequate controls to prevent allergen cross-contact and ensure proper allergen labeling, specifically:

• Cross-contact: Shared equipment was used to manufacture bread products containing milk, egg, sesame and other allergens without adequate scheduling or segregation practices. For example, sesame seeds were found on non-sesame products such as Burly hamburger buns and Sour Charlie bread.
• Labeling: Product labels lacked complete allergen declarations. For instance, the “Contains” statement on sesame hamburger buns did not list sesame, despite its presence in the product.

Sanitation and pest control issues

FDA investigators identified multiple sanitation and pest control deficiencies, including:

• Unclean equipment: Food-contact surfaces on bread slicers, mixers, and conveyors had visible residue post-sanitation. Employees continued using these machines without corrective action.
• Facility conditions: Exposed bread was observed cooling under ceiling vents covered in dust, flaking paint, and dangling insulation. Additionally, black mold-like substances were found in cooling areas.
• Pest infestation: Investigators observed live insects in ingredient bins and evidence of pest activity throughout the facility, including insect trails and contaminated raw materials.

Employee hygiene violations

Employees working with food products were observed failing to follow proper hygiene practices. For example, an employee drank from a personal container while wearing gloves, and then handled exposed RTE bread without washing their hands or changing gloves. Hair restraints were also inconsistently used.

FDA comments and expectations

The FDA emphasized that these violations render Salt City Baking’s RTE bread products adulterated under federal law, as they were prepared under insanitary conditions that could lead to contamination. The agency also noted that the company must train all personnel on food hygiene and safety and maintain documentation of this training.

The full warning letter can be viewed here.

(To sign up for a free subscription to Food Safety News, click here.)