FDA 483 - Fong Kee Tofu Co., Inc. - April 02, 2021

Fong Kee Tofu Co., Inc. in San Francisco, CA, a tofu manufacturer, was inspected and found to have significant deviations from a Consent Decree, including failures in their sanitation control program, lack of proper auditing, and inadequate labeling review. The inspection also revealed a lack of appropriate quality control for food additives, an unwritten and unimplemented food safety plan with multiple unaddressed hazards, and widespread insanitary conditions throughout the facility, including poor operational controls and maintenance issues.