FDA WARNING_LETTER - Del Bueno - October 20, 2010

The FDA inspected Del Bueno's cheese processing establishment in Grandview, Washington, from October 18-20, 2010. Environmental swabs collected on October 19, 2010, tested positive for Listeria monocytogenes, rendering cheese products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Subsequently, on November 1, 2010, two finished Queso Fresco Cheese samples collected at retail also tested positive for L. monocytogenes, causing them to be adulterated under 21 U.S.C. § 342(a)(1) as they contained a poisonous substance. Pulsed Field Gel Electrophoresis (PFGE) analysis revealed that the L. monocytogenes strains from FDA environmental and finished product samples were indistinguishable from each other and from strains found by the Washington State Department of Agriculture (WSDA) in March and November 2010. This indicates a persistent strain and inadequate sanitation efforts. The firm conducted a voluntary recall on November 17, 2010. The FDA requires the firm to notify them in writing within 15 working days of corrective actions taken to control L. monocytogenes and prevent product contamination, including supporting documentation. Failure to correct these violations may result in further regulatory action, such as product seizure or injunction.