FDA 483 - Bimbo Bakeries USA - June 27, 2025

During an inspection conducted from June 23 to June 27, 2025, the FDA issued a Form 483 to Bimbo Bakeries USA, identifying significant observations related to food safety practices. The inspection revealed that the company’s hazard analysis was deficient, specifically failing to identify recontamination by environmental pathogens as a hazard requiring preventive controls for ready-to-eat (RTE) bread products. This oversight was compounded by inadequate employee hygiene, with investigators observing staff touching non-food contact surfaces and then RTE bread without glove changes or hand sanitization. Additionally, employees’ soiled clothing was noted to contact exposed bread loaves. The inspection also highlighted failures in following the company’s environmental monitoring program (EMP). A presumptive positive for Listeria sp. in a post-bake drain led to unclear re-testing and delayed corrective cleaning. Critically, despite EMP protocols requiring production halts and product holds for presumptive positives, production continued, and products were released without documented justification. Furthermore, a repeat observation from a 2018 inspection noted that human food by-products, intended for animal feed, were found to contain foreign materials such as used gloves, masks, and plastic packaging. These observations indicate non-compliance with the Federal Food, Drug, and Cosmetic Act, necessitating prompt and comprehensive corrective actions by Bimbo Bakeries USA to ensure regulatory adherence and product safety.