FDA WARNING_LETTER - YeYa Products Corp - July 26, 2010

The FDA conducted an inspection of YeYa Products Corp.'s food processing facility in Miami, FL, from July 22-26, 2010, revealing serious violations of 21 CFR Part 110 (Current Good Manufacturing Practice). These conditions caused products like YeYa Plain, Butter, and Garlic crackers to be adulterated under section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, due to preparation under insanitary conditions. Key violations included: failure to maintain equipment, containers, and utensils to prevent contamination (21 CFR 110.80(b)(7)); failure to store raw materials to protect against contamination (21 CFR 110.80(a)(1)); failure to properly clean and sanitize equipment, exemplified by using undiluted bleach (21 CFR 110.35(a)); failure to design and construct equipment to preclude food adulteration, such as using a splintered wooden box and a frayed conveyor belt (21 CFR 110.40(a)); facility construction issues, including walls, ceilings, and floors not being adequately cleanable or in good repair, leading to condensate and dirt accumulation (21 CFR 110.20(b)(4)); and failure to maintain the building and fixtures in a sanitary condition, specifically noting a mold-like substance on the proofer ceiling (21 CFR 110.35(a)). The FDA requires a written response within fifteen working days detailing corrective actions, including documentation like photographs of structural repairs. Failure to correct these violations may result in regulatory actions such as product seizure or injunctions.