FDA WARNING_LETTER - Radno Inc. dba GoldCoast Salads - August 08, 2013

The FDA inspected DNO, Inc.'s processed fruit and vegetable facility in Columbus, OH, from August 1-8, 2013. Environmental swabs collected during the inspection revealed *Listeria monocytogenes* in ten of eighty-eight swabs, including seven from food-contact surfaces. This finding renders the products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Prior to the FDA inspection, DNO, Inc. had reported *L. monocytogenes* in sliced zucchini product via the Reportable Food Registry on July 25, 2013, and voluntarily recalled zucchini products sold between July 1-24, 2013.

While DNO, Inc. submitted a written response on September 3, 2013, outlining corrective actions such as produce washing, surface sanitization, equipment cleaning, employee designation, access restrictions, and environmental monitoring program alterations, the FDA deemed the response insufficient. Specific details were lacking regarding changes to product handling, movement, access restrictions, cleaning/sanitizing methods, sanitizer rotation, and the revised environmental monitoring program, including testing frequency, sample locations, and corrective actions for positive findings.

The FDA emphasized the need for detailed plans, including diagrams for product flow and employee movement, specifics on cleaning procedures, and a comprehensive environmental monitoring plan with defined corrective actions. Failure to promptly correct these