FDA WARNING_LETTER - California Bread Co. - November 28, 2023

The FDA inspected a manufacturing facility at 681 Anita St, Ste 106, Chula Vista, CA, from October 24 to November 28, 2023, 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 facility's Egg Bread product was also found to be adulterated under section 402(c) of the Act due to an unsafe color additive, and several products were misbranded under section 403 of the Act due to labeling violations.

Key violations include: 1. **Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117 Subpart C):** * Failure to include procedures for allergen labeling in the written allergen preventive control, specifically regarding milk allergen in sweet whey for La Torta (Telera) bread, leading to undeclared milk and a voluntary recall. * Failure to identify and evaluate undeclared color additives (e.g., FD&C Yellow #5 in Egg Bread) as a hazard requiring a preventive control. * Failure to implement preventive controls for environmental pathogens, evidenced by observations of a discolored, frayed, and unsmooth food-contact conveyor belt on a slicer during production of RTE La Torta Bread.

2. **Color Additive Labeling:** Egg Bread