FDA WARNING_LETTER - Tan Nam Corporation - March 20, 2025

On August 25, 2025, the FDA issued a Warning Letter to Tan Nam Corporation following an inspection of its Rosemead, CA facility from February 27 to March 20, 2025. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117), deeming the company"s soybean products adulterated under the Federal Food, Drug, and Cosmetic Act. Key violations included the failure to submit the required attestation for a Qualified Facility (21 CFR 117.201). More critically, the company lacked adequate controls to prevent microbial growth in its ready-to-eat and ready-to-drink soybean products. Specifically, raw soybeans were soaked for extended periods at temperatures conducive to *Bacillus cereus* growth. Additionally, finished products like soybean curd, soy milk, and soybean pudding were not properly cooled after cooking and were observed being distributed at ambient temperatures, increasing the risk of pathogen proliferation. The FDA noted high internal product temperatures before distribution. Furthermore, several product labels, including Fresh Soy Milk (No Sugar), Soybean Curd (Tofu), and Fresh Soybean Pudding, were found to have significant misbranding violations under 21 CFR Part 101. The company"s prior response to inspection observations was deemed inadequate, requiring Tan Nam Corporation to promptly address these serious violations to ensure the safety and proper labeling of its food products.