Ajinomoto Co., Inc. – FDA 483, Nov 14, 2025

An FDA Form 483 was issued to Mr. Kittaka Koji, General Manager of the Tokai Plant, following an inspection conducted from November 10 to November 14, 2025. The inspection revealed significant deficiencies in the plant's quality management systems, particularly concerning data integrity and equipment use documentation.The first observation highlighted inadequate controls over computerized systems. Specifically, users with "Analyst" and "Reviewer" privileges could delete critical data from the Infrared Spectroscopy Machine software used for identity testing. Furthermore, "Reviewer" users could alter the system's date and time, and one individual held dual login accounts, increasing the risk of unauthorized data manipulation.The second observation detailed non-contemporaneous and incomplete records for equipment use. Logs for API production equipment were not completed in the production areas. Instead, a single log for all equipment was filled out in the Document Control Room by a "Leader" at the start of production and never left the room. These logs also lacked specific dates, times, and the names of the individuals operating each piece of equipment, with only a single "Leader" initialing for all operations.These observations indicate a need for immediate corrective action to ensure the integrity of electronic records and the accuracy of production documentation, aligning with regulatory expectations for pharmaceutical manufacturing. The company is expected to provide a comprehensive response detailing how these compliance issues will be resolved to prevent recurrence.