FDA WARNING_LETTER - Lumen Soy Foods, LLC - March 11, 2011

On February 22-25, 28, March 3, 4, 7, 9, and 11, 2011, FDA investigators inspected Lumen Soy Foods, LLC's facility in Lake Charles, Louisiana, revealing serious violations of Current Good Manufacturing Practice (21 CFR Part 110). These conditions caused food products to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Significant violations included: 1. Failure to exclude pests and protect food from contamination (21 CFR 110.35(c)). Evidence of widespread rodent activity was observed in the warehouse, packing room, and ingredient storeroom. This included fresh rodent excreta pellets, apparent rodent hairs, and fluorescing rodent urine stains on textured vegetable protein bags and other ingredients. A live rodent was also observed. FDA lab tests confirmed rodent contamination. 2. Failure to provide adequate screening or other pest protection (21 CFR 110.20(b)(7)). Investigators observed multiple gaps and openings beneath roll-down doors in the warehouse, unscreened ceiling vents, and a hole in the warehouse wall, all providing potential pest entry points near food products.

The FDA issued a FORM FDA 483 on March 11, 2011. The firm voluntarily destroyed contaminated ingredients and products on