FDA WARNING_LETTER - Lifesoy, Inc. - May 30, 2008

On August 8, 2008, the FDA issued a Warning Letter to Lifesoy, Inc. following an inspection on May 29-30, 2008, which revealed insanitary conditions and serious violations of Current Good Manufacturing Practice (GMP) regulations (21 CFR Part 110). The FDA determined that Lifesoy's food products, including soy beverages and tofu, were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Temperature Control:** Perishable products like soy milk and tofu were not refrigerated during transport or sale, violating 21 CFR 110.80(b)(3). 2. **Contamination Prevention:** An employee caused dirty water to splash into in-process tofu and onto food contact surfaces, violating 21 CFR 110.80(b)(2). 3. **Pest Exclusion:** A domestic cat was housed in the processing area, guard dogs roamed the facility nightly, rodent excreta was found above the processing room, and an open exterior door allowed numerous insects into the production area, violating 21 CFR 110.35(c). 4. **Equipment Cleanability:** Non-food grade plastic horticulture racks with grooves and holes, difficult to clean, were used for tofu pressing, violating 21 CFR