FDA EIR - Burnette Foods, Inc - February 15, 2008

An extensive FDA inspection of New Era Canning Company in New Era, MI, was conducted from November 26, 2007, to February 15, 2008. The inspection, focusing on Low Acid Canned Food (LACF) products like green beans and pumpkin, revealed severe deficiencies under LACF Regulations, particularly 21 CFR Part 113. These violations included failure to correctly identify and manage process deviations, such as not timely evaluating defective lots and lack of current temperature distribution studies for retort systems. Critically, viable Clostridium botulinum spores were detected in finished products and cooling water, alongside other significant water system issues. The company also failed to ensure qualified personnel conducted can seam evaluations, leading to unacceptable loose seams, and had inadequate retort traffic control, risking commingling of uncooked and cooked products. Furthermore, can codes were either missing or lacked establishment identification. As a direct consequence, approximately (b)(4) worth of canned food was seized by the State of Michigan, and FDA issued an Emergency Permit Order, banning interstate shipment of all LACF products. The company initiated four voluntary recalls for various green bean, chili bean, and garbanzo bean products due to botulinum spore contamination and other issues. In response, New Era Canning Company implemented several corrective actions, including can seam evaluation training, installing new systems around retorts, conducting temperature distribution studies on all retorts, and updating can codes to include an establishment identifier.