FDA EIR - ADM Southport - February 11, 2021

This FDA Preventive Controls inspection of Archer Daniels Midland Company (ADM) at its Southport, NC facility occurred from February 9 to February 11, 2021. The inspection focused on the firm's production of food additives, including citric acid, sodium citrate, and potassium citrate, which are distributed nationally and internationally. While no objectionable conditions were observed during this particular inspection, the regulatory review highlighted opportunities for enhancement within ADM's hazard analysis and preventive controls program. Inspectors noted that the firm's risk assessment did not fully address the potential chemical hazard of unapproved additives or colors in certain raw materials. It was suggested that ADM obtain more specific documentation from suppliers to confirm compliance with FDA regulations (21 CFR 189, 21 CFR 81.10) for these ingredients, ensuring any additives or colors used meet specific conditions of use. Additionally, it was recommended that ADM improve its record-keeping for metal detectors, a critical processing control, by documenting the actual times of checks rather than just pass/fail results. Management was receptive to the discussions and findings, demonstrating a commitment to continuous improvement in adhering to the regulatory framework for food additives. The report also indicated that ADM had already addressed observations from a previous inspection, such as resolving issues with dark liquid droplets in packaging areas.