FDA EIR - Stello Foods Inc - August 03, 2021

A Food and Drug Administration (FDA) inspection of Stello Foods Inc. in Punxsutawney, PA, was conducted from August 2-3, 2021. This FSMA limited scope inspection, guided by the Preventive Controls and Sanitary Human Food Operations program, focused on the company's manufacturing of acidified foods, dressings, and condiments. The inspection identified two primary objectionable conditions. First, the compressed air system, utilized for cleaning food contact surfaces, was not adequately filtered to prevent potential contamination from lubricants or foreign materials, violating good manufacturing practices (21 CFR 117.40(g)). Second, the company's procedures for corrective actions were deemed insufficient because responses to presumptive positive environmental samples for Salmonella and Listeria were completed but not properly documented in writing (21 CFR 117.150(a)(2)). Additionally, inspectors noted general sanitation concerns, including the use of rusty, fiberboard-backed clipboards in food production areas, which cannot be effectively sanitized. Documentation of cleaning schedules for facility fans was also found to be incomplete. In response, Stello Foods management committed to installing filters in the air supply system by August 31, 2021, and to completing written documentation for past environmental sampling corrective actions by August 4, 2021. Management also agreed to replace the problematic clipboards by August 20, 2021, and addressed fan cleaning procedures immediately.