FDA WARNING_LETTER - Edenic Soy & Tofu, Inc - February 08, 2011

On July 26, 2011, the FDA issued a Warning Letter to Edenic Soy & Tofu, Inc. following an inspection from February 1-8, 2011. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their tofu and soy drink products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Additionally, product labels for Edenic Firm Tofu and Edenic Soy Drink were found to be misbranded under Section 403 of the Act.

CGMP violations included inadequate plumbing (dead legs, lack of backflow prevention, direct floor drainage, poor floor drainage leading to standing water), improper employee hygiene (failure to wash hands after touching floor, failure to cleanse/sanitize gloves between tasks), use of a frayed metal screen in direct contact with tofu, improper storage of food-contact containers, inadequate cleaning of food-contact surfaces (mold-like substance on packaging machine, organic matter on chain), use of unsanitary and poorly maintained equipment (shredded wooden stirring utensil, rough welded surface on soy drink funnel), pest harborage (vines on outer wall), inadequate employee attire (no hairnets/beard covers), and poor plant construction/maintenance (shredded paint, cracked production room floor).

Labeling violations included mis