FDA 483 - Tropical Bakery Wholesale Corp - November 18, 2022

An FDA inspection of Tropical Bakery Wholesale Corp in Hialeah, FL, a bread and pastries manufacturer, revealed significant deficiencies in sanitation, supply-chain management, and facility maintenance. The inspection identified repeat observations concerning the lack of adequate sanitation verification procedures, failure to implement a written supply-chain program for identified hazards like Mycotoxins, and a plant not constructed to facilitate sanitary operations, including cracked flooring and standing water. These issues indicate a concerning pattern of non-compliance.