Simplot Frozen Vegetables LLC – FDA EIR, Oct 4, 2019

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.