Marin Baking LLC – FDA Warning Letter, Nov 26, 2024

On May 28, 2025, the FDA issued a Warning Letter to Marin Baking LLC following an inspection from November 14-26, 2024, at their San Rafael, CA, ready-to-eat (RTE) bread product manufacturing facility. The inspection revealed significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

Key violations include: 1. **Adulterated Products:** RTE bread products were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions, evidenced by collected filth samples containing rodent excreta pellets and multi-stage beetles (adult and larva). 2. **Inadequate Allergen Controls (21 CFR 117.135(c)(2)):** * The Food Safety Plan lacked procedures for preventing allergen cross-contact on shared food-contact equipment for finished products. * Sanitation procedures were not fully followed; daily sanitation did not include all shared food-contact equipment (e.g., wire racks cleaned every 4 months). * Observed sesame seeds on non-sesame bread products (Sweet Longie, Ciabatta) and baking trays. * Allergen controls did not ensure correct labeling for finished products, with