FDA WARNING_LETTER - Nicho Produce Co., Inc. - December 16, 2011

The FDA inspected Nicho Produce Company, Inc.'s facility from December 9-16, 2011, following recalls of their shredded lettuce and spinach due to *Listeria monocytogenes* (L. mono) contamination. The inspection found serious Current Good Manufacturing Practice (CGMP) violations and confirmed L. mono presence, including on direct food-contact surfaces, rendering products adulterated under 21 U.S.C. 342(a)(4).

Environmental sampling (FDA sample #641168) yielded L. mono from 12 of 72 swabs, including direct food-contact surfaces like a plastic block, drier spinner, and squeegee. One isolate matched a USDA spinach product strain, and others matched USDA lettuce isolates, indicating cross-contamination.

Violations included: 1. **Failure to minimize microbial growth/contamination (21 CFR 110.80(b)(2)):** Employees handled ready-to-eat produce with unsanitized gloved hands after touching contaminated surfaces (e.g., a shovel and squeegee that tested positive for L. mono). 2. **Inadequate cleaning/sanitizing of equipment (21 CFR 110.35(a)):** Food residue (broccoli florets, dewatering belt residue) was observed on equipment after cleaning and sanitizing. 3. **Inadequate plumbing