FDA 483 - Ajinomoto Health & Nutrition North America, Inc. - September 12, 2025

An FDA inspection of Ajinomoto Health & Nutrition North America, Inc. in Eddyville, Iowa, revealed widespread deficiencies in quality unit oversight, manufacturing process controls, and data integrity for crude intermediates. The firm failed to approve batch records, validate processes, establish stability data, and maintain adequate specifications, with several issues being repeat observations. Additionally, insanitary conditions and insufficient controls over computerized systems were noted, indicating significant non-compliance across critical operational areas.