FDA WARNING_LETTER - Roselife, LLC - June 06, 2008

On June 3-6, 2008, the FDA inspected Roselife, LLC's soymilk and ready-to-eat (RTE) tofu manufacturing facility in Ann Arbor, Michigan, finding significant deviations from cGMP regulations (21 CFR Part 110). These violations render the foods adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Specific sanitation violations include: 1. **Equipment Design and Maintenance (21 CFR 110.40(a)):** Non-food-grade aquatic submersible pumps with electrical cords were immersed in raw soymilk and used to transfer ice water into finished tofu, posing contamination risks due to being difficult to clean. 2. **Minimizing Contamination (21 CFR 110.80(b)(2)):** An employee dumped liquid into a floor drain near tofu processing, causing splatter onto cheesecloth used for uncovered in-process tofu. A pressurized hose was used to rinse the floor near uncovered soaking soybeans, causing splatter. Wire mesh screens with tofu residue were placed directly into sanitizer without prior washing. 3. **Plant Construction and Maintenance (21 CFR 110.20(b)(4)):** The tofu production room floor had deep cracks and depressions, preventing proper drainage and allowing contamination