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

An FDA inspection of Ajinomoto Company Inc.'s Kawasaki Plant, an API manufacturer, concluded on February 21, 2025, revealing several significant quality system deficiencies. The inspection identified three primary observations requiring the company's attention to ensure compliance with good manufacturing practices. The most prominent issue involved the inadequacy of root cause investigations. The FDA noted that five out of five reviewed investigations into production deviations and laboratory out-of-specification results failed to thoroughly identify the true root cause and establish effective actions to prevent recurrence. Specific examples highlighted problems such as unapproved engineering changes impacting equipment, yield issues stemming from unaddressed design differences, operational errors compounded by incomplete standard operating procedures (SOPs), insufficient documentation for critical equipment checks, and contamination linked to inadequate cleaning instructions in SOPs. In each case, investigations addressed immediate corrections but did not sufficiently explore underlying systemic failures or propose robust preventive measures. Further observations included a lack of control over laboratory sample preparation worksheets, with no system in place to manage their issuance or track duplicate usage. Additionally, the company lacked data to demonstrate that materials used in the construction of various API production tanks, such as the Tank and Storage Tanks, are not leaching into the active pharmaceutical ingredients. To address these findings, Ajinomoto Company Inc. is expected to promptly develop and implement comprehensive corrective and preventive actions for each observation, ensuring robust quality systems for manufacturing and laboratory controls.