FDA WARNING_LETTER - Salt City Baking Company, LLC - July 11, 2024

The FDA inspected Mr. Fox's manufacturing facility at 60 E Gordon Avenue, Murray, Utah, from July 8-11, 2024, revealing significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The ready-to-eat (RTE) bread products manufactured were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: 1. **Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):** * Failure to conduct a hazard analysis for environmental pathogens (e.g., Salmonella) for RTE bread, despite products being exposed to the environment and handled by employees post-baking without further lethal treatment. This includes a lack of environmental monitoring for sanitation effectiveness. * Observations: Employee drinking from personal container with gloved hands then touching exposed RTE bread; food residue on RTE bread slicer and bun slicer after sanitation. * Failure to consider mycotoxins (e.g., deoxynivalenol (DON) in wheat flour) as a hazard requiring a preventive control (supply-chain program) and implement an approved supplier and verification program. * Inadequate written allergen preventive controls (21 CFR 1