FDA 483 - Ajinomoto Company Inc. - February 21, 2025

Between February 17 and 21, 2025, the U.S. Food and Drug Administration (FDA) inspected the Ajinomoto Company Inc. manufacturing facility in Kawasaki-City, Japan. This facility, which specializes in producing Active Pharmaceutical Ingredients (APIs), was issued a Form 483 following several observations regarding its quality control and manufacturing standards. A major concern identified was the inadequacy of investigations into production errors and laboratory testing failures. The company repeatedly failed to identify the true root causes of deviations or implement effective measures to prevent these issues from recurring. Specific examples included unauthorized equipment changes performed without oversight, equipment design flaws that affected yields, and insufficient cleaning procedures that led to sample contamination. Additionally, the inspection revealed a lack of control over laboratory documentation, as there was no system to track the issuance of sample preparation worksheets. The FDA also noted that the company lacked data to prove that the materials used in its production and storage tanks were safe and would not contaminate the APIs. Within the regulatory framework of pharmaceutical manufacturing, these findings represent preliminary assessments of non-compliance. Ajinomoto is expected to respond to these observations by submitting a comprehensive plan for corrective and preventative actions to address the identified safety and quality risks.