FDA WARNING_LETTER - The Bonami Baking Company, Inc. - April 22, 2022

The FDA inspected Bonami Baking Company's facility in Pittsburg, CA, from April 4-22, 2022, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (21 CFR Part 117). The ready-to-eat (RTE) bakery products were deemed adulterated due to insanitary conditions, and the firm failed to comply with preventive controls. Additionally, significant labeling violations (21 CFR Part 101) caused products to be misbranded.

Key violations include the absence of a comprehensive food safety plan, including hazard analysis, preventive controls (for allergens, environmental pathogens, bacterial pathogens, and mycotoxins), a supply-chain program, recall plan, monitoring, corrective action, and verification procedures. Specific issues noted were inadequate allergen cross-contact controls (e.g., improper cleaning of shared equipment/utensils), failure to evaluate environmental pathogens for RTE products, and lack of validation for oven parameters to control bacterial pathogens. The firm also lacked a supply-chain program for mycotoxins in ingredients.

CGMP violations included poor facility maintenance (torn plastic curtains, overflowing drains, cracked floors, pest infestations including rodent excreta and live ants, and structural gaps allowing pest entry). Equipment and utensils were not adequately cleanable, with observations of scratched plastic bowls shedding fragments, food debris buildup on conveyor belts and wooden prep tables, and outdoor storage of