FDA EIR - Simplot Frozen Vegetables LLC - December 11, 2019

An FDA inspection of Simplot Frozen Vegetables, LLC in Pasco, WA, was conducted from December 9-11, 2019. This targeted inspection served as a compliance-issued follow-up to a Class I recall (F-0202-2020) for a vegetable blend product containing undeclared soy allergen (edamame) that was inadvertently mislabeled as lima beans. The inspection was a Good Manufacturing Practice (GMP) and full-scope Preventive Controls for Human Food (PCHF) assessment, covering applicable subparts of 21 CFR 117, with a focus on the recall and the firm's preventive controls.

No new FDA Form 483, Inspectional Observations, was issued during this inspection. Simplot Frozen Vegetables, LLC had implemented corrections for four observations from a previous inspection (September-October 2019), which included improving written corrective action procedures for sanitation and process controls, ensuring cleanliness of food contact surfaces, and enhancing sanitation monitoring. In response to the allergen recall, the company implemented an expanded training program, new Standard Operating Procedures (SOPs) for allergen control audits, and revised protocols for the disposal of allergen-containing totes. The firm successfully accounted for and destroyed 100% of the recalled product.

At the close-out meeting, management discussed two items for further attention: improving employee accessibility to visual allergen confirmation systems throughout the facility and ensuring the accurate reflection of alteration dates on all documents.