Bimbo Bakeries USA Inc. – FDA 483, Jul 16, 2025

An FDA Form 483 was issued following an inspection conducted from July 14-16, 2025, at a facility managed by William C. Meadows, identified as a Plant Manager/Bakery Leader. While the specific company name is not provided, the establishment type appears to be a bakery. The primary observation noted by Investigator Rashonda N. Rucker was the lack of adequate sanitary facilities and accommodations. Specifically, during a walkthrough on July 16, 2025, it was observed that the handwashing sink near Line 1 in the scaling area was not dispensing soap. This is a critical repeat observation, having been cited in a previous inspection on September 19, 2024. This observation indicates conditions or practices that may lead to food being prepared, packed, or held under insanitary conditions, as outlined in Section 704(b) of the Federal Food, Drug and Cosmetic Act. The firm is required to review these inspectional observations and consider implementing corrective actions to ensure compliance with regulatory standards for food safety and hygiene. The document emphasizes that these are observations, not a final determination of compliance, and encourages the firm to discuss or submit corrective actions.