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The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters.

Warning letters often are not issued until a company has been given months to years to correct problems. Bimbo Bakeries USA Inc. Horsham, PA The FDA has warned a food firm in Pennsylvania after an inspection found serious violations of the Federal Food, Drug, and Cosmetic Act, including misbranded products that are false or misleading.



In a June 17, 2024, warning letter, the FDA described an October 3-27, 2023, inspection of Bimbo Bakeries USA, Inc.’s facility in Phoenix, AZ. The FDA also commissioned the Kansas Department of Agriculture employees to inspect the firm’s facility in Topeka, KS.

Based on the inspectional findings and review of the firm’s product labels, the FDA has identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Some of the violations: 1. The firm’s Sara Lee brand Artesano Brioche, Delightful Multigrain, Artesano Golden Wheat, and Artesano Smooth Multigrain ready-to-eat (RTE) bread loaf products are misbranded in that the product labels are false or misleading because they include sesame seeds in the ingredient and “Contains” statements; however, sesame seed is not an ingredient in the product formulations.

The B.

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