FDA WARNING_LETTER - Bread and Cie Wholesale, LLC - January 03, 2020

The FDA inspected a ready-to-eat (RTE) bakery manufacturing facility from December 19, 2019, to January 3, 2020, 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 facility's food products were deemed adulterated due to insanitary conditions, and significant labeling violations caused products to be misbranded under 21 U.S.C. § 343.

Key violations include: - **Lack of Hazard Analysis:** Failure to identify and evaluate known or foreseeable hazards such as allergens, environmental pathogens (Listeria monocytogenes, Salmonella), mycotoxins, and vegetative pathogens (E. coli, Salmonella). - **No Preventive Controls:** Failure to implement preventive controls for identified hazards, including process, allergen, sanitation, and supply-chain controls, and a recall plan. - **Missing Food Safety Plan:** Absence of a comprehensive written food safety plan, including hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures. - **Insufficient Cleaning:** Failure to adequately clean utensils and food contact surfaces, leading to allergen cross-contact between different products. - **Poor Hygienic Practices:** Employees engaged in practices that could recontaminate RTE food, such as touching trash cans then food, using bare hands