FDA WARNING_LETTER - Cafe Valley Bakery, LLC - December 17, 2019

The FDA inspected Café Valley Bakery, LLC's ready-to-eat (RTE) bakery manufacturing facility from November 5 to December 17, 2019, identifying serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Environmental samples confirmed the presence of *Listeria monocytogenes* (L. monocytogenes), including strains found during prior 2016 and 2018 inspections, indicating resident pathogens. This led to the determination that the bakery products were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included the failure to implement adequate sanitation controls to prevent L. monocytogenes (21 CFR §§ 117.135(a)(1) and (c)(3)), failure to conduct operations with adequate sanitation principles to prevent contamination (21 CFR 117.80(a)(1) and (4))—citing issues like insufficient cleaning, unsanitized carts, and employee cross-contamination—plant design not facilitating sanitary operations (21 CFR 117.20(b) and (b)(2)), and failure to maintain facilities in repair (21 CFR 117.35(a)).

The firm's January 6, 2020, response outlined corrective actions, such as hiring a third-party cleaning company, retraining staff, changing sanitizers, increasing environmental swabbing, and addressing facility repairs. FDA will verify the effectiveness of these actions during future inspections. Failure to promptly correct violations may result in legal action, including seizure and injunction, and the assessment of reinspection fees.