FDA WARNING_LETTER - Gills Onions, LLC - June 01, 2012

The FDA issued a Warning Letter to Gills Onions, LLC following inspections and sample collections in 2012. Finished product samples of "Fresh Diced Yellow Onions" and "3/8" Diced Yellow Onion" collected in July and August 2012 yielded Listeria monocytogenes (L. monocytogenes) isolates that were indistinguishable by PFGE analysis. These products were deemed adulterated under 21 U.S.C. §342(a)(1) due to containing a poisonous substance. A May-June 2012 inspection also found L. monocytogenes in 13 environmental swabs, including two from food contact surfaces, with isolates indistinguishable from those in finished products. This indicated inadequate corrective actions, a facility harborage problem, and products prepared under insanitary conditions, leading to adulteration under 21 U.S.C. §342(a)(4). The firm had conducted voluntary recalls and reported corrective actions, but ongoing concerns included finding Listeria on a food contact surface after renovations. The FDA recommended developing a comprehensive Listeria control plan for raw product and facility colonization, increasing food contact surface swabbing to at least weekly, and implementing a written environmental monitoring plan with defined corrective actions. The letter emphasized the firm's responsibility to comply with the Act and 21 CFR Part 110 (CGMP) and required a written response within 15 working days detailing corrective actions and requesting a meeting to discuss facility repairs, SSOPs, and Listeria control plan revisions. Failure to comply could result in enforcement actions like product seizure, injunction, and re-inspection fees.