# FDA WARNING_LETTER - Marathon Ventures, Inc. - June 04, 2019

Source: https://www.keypedia.com/records/warning_letter/marathon-ventures-inc/427f7d7b-58b5-48e1-8a9d-512129dc2724

> FDA WARNING_LETTER for Marathon Ventures, Inc. on June 04, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Marathon Ventures, Inc.
- Inspection Date: 2019-06-04
- Product Type: Food
- Office Name: Office of Human and Animal Food West Division II
- Summary: 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.

## Related Officers

- [Division Director](https://www.keypedia.com/people/cheryl-a-bigham/10eee053-f062-4bcf-8e0f-2cd83f4928bf)

Company: https://www.keypedia.com/companies/marathon-ventures-inc/2a150a0a-f907-4867-86f6-aa2fef74f10c

Office: https://www.keypedia.com/offices/office-of-human-and-animal-food-west-division-ii/5966c263-9d27-4d22-8c31-6c72f83e0767