FDA WARNING_LETTER - Breadbox Co. - June 07, 2024

The FDA inspected a human food manufacturing facility at 10603 Painter Ave, Santa Fe Springs, CA, from May 10 to June 7, 2024, finding serious violations of the CGMP & PC rule (21 CFR Part 117). The facility manufactures ready-to-eat (RTE) bakery products, including breads, muffins, cookies, croissants, and bagels, which were deemed adulterated due to insanitary conditions.

Key violations include: - **No Food Safety Plan:** The facility lacked a food safety plan, hazard analysis, and preventive controls for any products. - **Undeclared Allergens:** Failure to identify and control allergens (wheat, soy, milk, eggs, tree nuts, sesame), leading to cross-contact (e.g., sesame seeds on non-sesame breadsticks, egg/soy residue on equipment used for non-allergen products). - **Undeclared Color Additives:** Failure to identify and control undeclared FD&C Yellow #5, which caused product recalls. - **Environmental Pathogens:** No controls for recontamination with environmental pathogens like Salmonella, evidenced by dirty racks, soiled mittens, and no environmental monitoring program. - **Mycotoxins:** Failure to identify and control mycotoxins in ingredients like wheat flour and tree nuts, and no supply-chain program for these hazards. - **No Recall Plan:** Absence of a