FDA WARNING_LETTER - Iowa Orchard LLC - December 18, 2013

The FDA issued a Warning Letter to Iowa Orchard LLC after apple cider samples collected on November 4 and December 18, 2013, from their Urbandale, IA facility tested positive for patulin. The samples showed mean patulin levels of 62.5 ppb and 55.7 ppb, respectively. These levels exceed the FDA's action level of 50 ppb for patulin in apple juice, causing the product to be adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §342(a)(1)]. This indicates the product contains a poisonous or deleterious substance potentially injurious to health, as prolonged exposure to high patulin levels poses a health hazard. The firm is required to take prompt corrective action to address the violation and prevent recurrence. Iowa Orchard LLC must notify the FDA in writing within fifteen working days, detailing the specific steps taken and providing documentation of correction, or explaining any delays. Failure to comply may lead to enforcement actions, including seizure of adulterated products and injunctions.