Ajinomoto Co. Inc. Kyushu Plant – FDA 483, Jul 18, 2025

During an inspection on July 18, 2025, the FDA cited Ajinomoto Co. Inc.'s Kyushu Plant, an API Manufacturer in Saga, Japan, for significant deficiencies in its quality system. The primary violation observed was a consistent failure to thoroughly review unexplained discrepancies or batch failures during the Active Pharmaceutical Ingredient (API) manufacturing process. Deviation reports frequently lacked scientific rationale, robust root cause analyses supported by data, or adequate technical evaluation and justification, compromising API quality and purity.

Specific examples highlighted these issues: a deviation (DEV_KY 2025 015) lacked evaluation and justification for hold time impact without validation; another (DEV_KY 2025 009) showed a production supervisor's approval to continue a process after an upper limit excursion without immediate Quality Assurance (QA) oversight, with QA notified days later. Furthermore, a bacteria testing failure (DEV_KY 2023 015) was linked to undocumented leaks in a "Near Miss/Trouble Logbook," which also lacked proper QA oversight.

These observations indicate non-compliance with current Good Manufacturing Practice (cGMP) regulations concerning deviation investigations and quality system controls for API manufacturing. Ajinomoto Co. Inc. is required to address these inspectional observations with comprehensive corrective actions, enhancing their deviation management system to ensure thorough investigations, scientific justification for conclusions, timely QA involvement, and effective oversight of production records to ensure product quality and regulatory compliance.