Didion Ethanol LLC – FDA EIR, Sep 26, 2012

This FDA Establishment Inspection Report summarizes a surveillance inspection of Didion Ethanol LLC, an ethanol manufacturing facility in Cambria, Wisconsin. The inspection was conducted on September 26, 2012, by the Wisconsin Department of Agriculture, Trade and Consumer Protection under contract for the FDA. Didion Ethanol LLC also produces and distributes co-products, such as Dried Distillers Grains (DDGs), Wet Distillers Grains (WDGs), and Condensed Distillers Solubles, which are sold as animal feed. The inspection focused on the firm's manufacturing practices for these animal feed components to ensure compliance with relevant regulatory frameworks, including the BSE (Bovine Spongiform Encephalopathy) rule outlined in 21 CFR §§ 589.2000 and 589.2001. No objectionable observations or significant deviations were identified during the inspection. Therefore, no FDA Form 483 was issued, and the inspection resulted in a "No Action Indicated" (NAI) classification. This outcome indicates that Didion Ethanol LLC was found to be in satisfactory compliance with regulatory requirements, and no corrective actions were deemed necessary.