FDA WARNING_LETTER - Middle East/ Soli's Baking Company, Inc. - January 10, 2025

The FDA issued a Warning Letter to Middle East/Soli's Baking Company, Inc. dba Middle East Baking Co. following an inspection of their pita manufacturing facility in Burlingame, CA, from November 20, 2024, to January 10, 2025. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Specifically, the company failed to implement effective measures to exclude pests and protect food from contamination, as required by 21 CFR § 117.35(c). Investigators observed numerous live and dead insects, including beetles and larvae, throughout the facility in critical areas such as mixers, dough processing equipment (divider, sheeter, proofer), ingredient bins, prep tables, and near the bulk flour silo. Laboratory analysis of collected samples confirmed widespread insect filth. These conditions led the FDA to determine that the food products, including pita and bagels, manufactured at the facility are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, meaning they were prepared or held under insanitary conditions that could render them injurious to health. Although the company provided responses to the initial inspection observations, the FDA found these actions insufficient. The Warning Letter underscores the FDA's ongoing concerns and requires the company to fully address these significant violations to ensure compliance with food safety regulations.