FDA EIR - ADM Southport - July 16, 2019

An FDA contract inspection of Archer Daniels Midland Company, a food additive manufacturer located in Southport, NC, was conducted on July 16, 2019. This inspection was performed by the North Carolina Department of Agriculture & Consumer Services Food & Drug Protection Division. The facility is responsible for producing granular and powder citric acid for human consumption.The primary observation identified during the inspection was the presence of dark liquid droplets on ceiling areas within a manufacturing room and the citric acid bagging room. This condition was noted as not maintaining the plant in a clean and sanitary state, which falls under 21 CFR 117.35(a) of the current good manufacturing practice regulations. No samples were collected, and no official adverse inspectional observations were issued. The inspection was classified as "Voluntary Action Indicated" (VAI). Management acknowledged the finding, agreeing to address the droplets and investigate their cause, attributing potential sources to washdown water or condensation from product buildup. While no formal mandatory actions were imposed, the company is expected to implement voluntary corrective measures.