FDA 483 - Alps Pharmaceutical Ind. Co., Ltd. - October 17, 2025

During an inspection conducted from October 13-17, 2025, the U.S. Food and Drug Administration issued a Form FDA 483 to Alps Pharmaceutical Ind. Co., Ltd., an Active Pharmaceutical Ingredients Manufacturer located in Hida City, Japan. This document details significant observations indicating non-compliance with regulatory standards, issued under the Federal Food, Drug and Cosmetic Act.

Key issues identified include the Quality Control laboratory's failure to follow its own written procedures for synchronizing laboratory instrument times. Specifically, High-Performance Liquid Chromatography (HPLC) hardware used for release testing of APIs shipped to US customers displayed incorrect times, deviating from established synchronization requirements. Furthermore, the microbiological laboratory lacked essential written procedures. An incubator used for critical testing was observed to contain mold and mildew due to the absence of a cleaning procedure. Additionally, there was no established procedure for properly labeling prepared media plates, leading to a lack of critical information such as analyst initials, inoculation dates, and sample identification for traceability.

Alps Pharmaceutical is expected to address these observations by implementing and documenting comprehensive corrective and preventive actions to ensure compliance with good manufacturing practices and prevent recurrence.