Allied Potato Processing LLC – FDA EIR, Mar 7, 2022

The FDA conducted a surveillance inspection of Idaho Natural & Organic Foods LLC, a potato product co-packer, from March 4-7, 2022. This comprehensive review, the firm's first FDA inspection, assessed compliance with Current Good Manufacturing Practices (cGMP) under 21 CFR Part 117, specifically focusing on preventative controls and sanitary operations for human food. The inspection covered receiving, storage, processing, packaging, and shipment of potato products like fries, diced potatoes, and tater tots. While no official FDA Form 483 (Inspectional Observations) was issued, the inspection identified and verbally discussed concerns regarding the firm's newly acquired warehouse. Issues included the presence of dust, debris, apparent insect webbing in corners, and unused equipment left from previous occupants. These conditions were noted as not facilitating proper maintenance and sanitary operations, specifically cited under 21 CFR 117.20(b). In response, company management, including the CEO and Plant Manager, acknowledged these observations during the closing meeting. They agreed to promptly address the issues by cleaning the warehouse to protect food and packaging materials from contamination, and by removing or cleaning the unused equipment to prevent pest harborage. This proactive agreement aims to ensure the facility fully supports sanitary food processing.