# FDA EIR - Simplot Frozen Vegetables LLC - October 04, 2019

Source: https://www.keypedia.com/records/eir/simplot-frozen-vegetables-llc/6153a70d-9db1-4f31-8003-537dcd53677c

> FDA EIR for Simplot Frozen Vegetables LLC on October 04, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Simplot Frozen Vegetables LLC
- Inspection Date: 2019-10-04
- Product Type: other
- Office Name: Seattle District Office
- Summary: An FDA inspection of Simplot-RDO LLC, a frozen vegetable processor in Pasco, WA, was conducted from September 23 to October 4, 2019. The inspection operated under 21 CFR 117 Preventive Controls, focusing on Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls, specifically targeting Listeria monocytogenes and Salmonella. The FDA issued a Form FDA 483 to management outlining several significant observations. These included the failure to implement adequate written corrective action procedures for both sanitation and process controls. Critically, sanitation control procedures were found insufficient to ensure the cleanliness of food contact surfaces, and proper written procedures for monitoring sanitation were absent. Beyond the formal observations, discussions with management highlighted issues such as chipping flooring, an unhygienic plastic utensil on a conveyor, and improper handling of animal feed. Furthermore, the firm had confirmed instances of Listeria monocytogenes in finished products that required reprocessing and identified numerous positive environmental Listeria spp. samples. Metal detectors also failed challenge tests on multiple occasions, necessitating product holds and reprocessing. Simplot-RDO LLC management committed to correcting the identified deficiencies and was advised to submit a formal written response to the FDA within 15 business days. The FDA also reminded the company of potential legal sanctions should serious deficiencies remain unaddressed.

## Related Documents

- [483 - 2019-10-04](https://www.keypedia.com/records/483/simplot-frozen-vegetables-llc/544179f4-ae21-4c47-9651-e6e85c1d559a)
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## Related Officers

- [Project Director](https://www.keypedia.com/people/jessica-clark/2a6267f9-bdda-4f6f-809e-23c4b5fac5cb)
- [company_representative](https://www.keypedia.com/people/mark-mckeller/2bd500c2-d01e-4ad4-9dc2-78effd939b6b)
- [Miriam R. Burbach](https://www.keypedia.com/people/miriam-r-burbach/68959b72-6f58-4d4b-9329-5109ffe8a649)
- [company_representative](https://www.keypedia.com/people/michael-r-davis/8410da04-5eac-4e4f-beda-b3b093287026)
- [company_representative](https://www.keypedia.com/people/jody-lynn-fleshman/a2406b40-6d57-4882-9703-9940f6838751)

Company: https://www.keypedia.com/companies/simplot-frozen-vegetables-llc/24e0d83b-02c3-463f-b925-4086ef95564a

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913
