FDA 483 - Grain Processing Corporation - February 13, 2020

An FDA inspection of Grain Processing Corporation in Muscatine, IA, an API manufacturer, revealed deficiencies in change control procedures. The firm failed to adequately evaluate the impact of changes to a drug substance filling line, leading to potential contamination and a subsequent customer complaint regarding out-of-specification moisture content in an EtOH product. This indicates a lack of proper control over manufacturing processes and product quality.