Marathon Ventures, Inc. – FDA Warning Letter, Jun 4, 2019

The FDA inspected a Ready-to-Eat (RTE) nuts and snack manufacturing facility in Bellevue, NE, from May 20 to June 4, 2019, finding serious violations of the CGMP & PC rule (21 CFR Part 117). Environmental samples revealed *Listeria monocytogenes* in the facility, leading to a determination that products were adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate Hazard Analysis:** Failure to identify recontamination with environmental pathogens as a hazard for RTE food exposed to the environment after the (b)(4) step, despite roof leaks and *L. monocytogenes* findings. 2. **Insufficient Sanitation Preventive Controls:** Five *L. monocytogenes* positive environmental samples (April-May 2019) in Zone 3, including RTE production areas, and an FDA-collected sample also positive. Additionally, inadequate wet cleaning procedures were noted for allergen control. 3. **Undocumented Corrective Actions:** Failure to document equipment (b)(4) after (b)(4) results and lack of documented investigations into the source of *L. monocytogenes* positive environmental samples. 4. **Poor Facility Maintenance:** Six new roof leaks observed during inspection, including over a nut roaster and in the warehouse where RTE products were stored.