FDA WARNING_LETTER - Wa Hen Dou Fu Soy Sauce Corporation - September 26, 2011

The FDA inspected Wa Hen Dou Fu Soy Sauce Corporation's facility in Sacramento, CA, on September 14, 21, 22, and 26, 2011. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) and identified Salmonella species Poly B in the facility, including on a direct food-contact surface. This led to a determination that the soy products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Specific violations include: * **Salmonella Contamination:** Four swabs tested positive for Salmonella species Poly B from a blue plastic strainer (food-contact surface), water hose nozzle, bottom of a white bucket used for "soy jello," and a stainless steel table. * **Poor Sanitary Practices (21 CFR 110.10(b)(5)):** Employees handled ready-to-eat products and food-contact surfaces with gloved hands that had contacted contaminated surfaces (floor, rusted hydraulic pump lever) without washing or sanitizing. * **Pest Control Deficiencies (21 CFR 110.20(b)(7), 110.35(c)):** Unscreened doors were left open, and dead cockroaches and live flies were observed in processing and office areas. *