FDA WARNING_LETTER - Oasis Brands, Inc - December 16, 2014

The FDA conducted inspections of Oasis Brands Inc.'s cheese manufacturing facility in Miami, FL, in August and October-December 2014. The inspections revealed that cheese products were adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Specifically, Lacteos Santa Martha Quesito Casero Fresh Curd was found to be adulterated with Listeria monocytogenes (L. monocytogenes) under 21 U.S.C. § 342(a)(1). Environmental and product samples confirmed a L. monocytogenes harborage problem within the facility, with isolates matching those found in products. The firm failed to adequately clean and sanitize equipment, as required by 21 CFR 110.35(a), contributing to contamination. Additionally, Oasis Brands Inc. failed to report two instances of L. spp. positive products to the Reportable Food Registry within 24 hours, a violation of 21 U.S.C. § 350f(d)(1) and a prohibited act under 21 U.S.C. § 331(mm). The firm committed to shutting down operations. The FDA requires documentation demonstrating adequate control of L. monocytogenes, including structural changes, sanitary SOPs, verification procedures, and environmental/product testing, if operations resume. Failure to promptly correct these violations may result in product seizure, injunction, and assessment of reinspection fees. A written response outlining corrective actions is required within fifteen working days.