FDA EIR - ADM Southport - March 19, 2014

This FDA Establishment Inspection Report details an inspection conducted at Archer Daniels Midland Co. from March 19 to March 25, 2014. The inspection was carried out under Compliance Program 7356.002 for Drug Manufacturing, specifically focusing on the company's Quality and Laboratory Control systems in adherence to current Good Manufacturing Practices (cGMP) for Active Pharmaceutical Ingredient (API) manufacturers. The firm manufactures food additives and Potassium Citrate USP.

The inspection concluded with a "No Action Indicated" (NAI) classification, indicating no significant deficiencies warranted a formal FDA-483 observation. However, verbal discussions highlighted two areas for improvement: the company's failure to close out several Corrective and Preventive Actions (CAPAs) in a timely manner, and an extended delay in management availability upon the investigator's arrival. The report also noted that the Drug Master File (DMF) for Potassium Citrate Monohydrate USP was closed in December 2011, and the firm updated CDER on its intentions, with the API label currently stating "Excipient /Food use." No formal regulatory actions were required, but the verbal discussions underscore an expectation for the company to address these operational efficiencies.