FDA 483 - Tropical Bakery Wholesale Corp - May 12, 2022

An FDA inspection of Tropical Bakery Wholesale Corp in Hialeah, FL, a manufacturer of bread and pastries, revealed significant deficiencies across multiple areas. The firm failed to implement adequate allergen and sanitation controls, lacked validation for process controls, and did not maintain a proper supply-chain program. Additionally, repeat observations highlighted issues with pest exclusion, inadequate temperature control for refrigerated products, and poor facility maintenance, indicating a systemic lack of control over food safety.