Golden Gate Soy Food, Inc. – FDA Warning Letter, Sep 21, 2012

On November 28, 2012, the FDA issued a Warning Letter to Golden Gate Soy Food, Inc. following an inspection from September 12-21, 2012. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their tofu and soy-based products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: - **Processes and Controls (21 CFR 110.80):** Employees used unsanitary water from a cold water bath containing non-food particles (metal, dirt, plastic) and a filthy 55-gallon drum with debris and stains for in-process and finished tofu. - **Equipment and Utensil Maintenance (21 CFR 110.80(b)(1)):** Equipment (cold water bath, metal vat, soybean grinder, whey separator, buckets) had visible residues and debris even after cleaning and sanitation. - **Equipment and Container Protection (21 CFR 110.80(b)(7)):** Aluminum trays for ready-to-eat product were stored on the floor, stained, and placed on a rusty cart, some soaked in cloudy water before use. - **Personnel Hygiene (21 CFR 110.10(b)):** Employees