FDA WARNING_LETTER - River Ranch Fresh Foods, LLC - October 26, 2011

The FDA conducted inspections of River Ranch Fresh Foods, LLC's Salinas, CA (October 13-26, 2011) and El Centro, CA (January 24-27, 2012) fresh produce processing facilities. The Salinas inspection was prompted by a State of Ohio sample of "The Farmer's Market" shredded lettuce yielding *Listeria monocytogenes* (L. monocytogenes). FDA environmental samples from the Salinas facility's barrel wash room and raw material cooler storage room floors also yielded an indistinguishable strain of L. monocytogenes. The El Centro inspection followed a Canadian Food Inspection Agency (CFIA) finding of L. monocytogenes in romaine lettuce from that facility.

Violations of FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) were observed at both facilities, rendering products adulterated under 21 U.S.C. § 342(a)(4). At Salinas, chipped and damaged concrete floors with standing water were found in the barrel wash room, main forklift entrance to the salad room, and raw material cooler storage room, violating 21 CFR 110.20(b) regarding facility construction for sanitation. At El Centro, an employee handling ready-to-eat food failed to wash/sanitize hands after handling trash utensils, violating 21 CFR § 110.10