FDA 483 - Ajinomoto Company Inc. - February 17, 2025

An FDA inspection of Ajinomoto Company Inc., an API manufacturer in Kawasaki-City, Japan, revealed significant deficiencies in their quality system. The firm failed to adequately investigate production deviations and out-of-specification results, often not identifying true root causes or implementing effective corrective actions. Additionally, the laboratory lacked proper control over sample preparation worksheets, and there was no data to support that materials used in production tanks were not additive to the APIs.