FDA 483 - Alps Pharmaceutical Industrial Co., Ltd. - October 13, 2025

During an FDA inspection conducted from October 13-17, 2025, Alps Pharmaceutical Ind. Co., Ltd., an Active Pharmaceutical Ingredients (API) manufacturer located in Hida City, Japan, received a Form FDA 483 outlining two significant observations. These observations signal potential deviations from Good Manufacturing Practices and require the company to implement corrective actions.The first observation pertained to the Quality Control (QC) laboratory"s failure to follow its established written procedure for synchronizing laboratory instrument times. Specifically, the hardware display times of High-Performance Liquid Chromatography (HPLC) instruments, used for release testing of U.S.-bound APIs, were not synchronized with the network LabSolution software, exceeding the specified tolerance.The second observation highlighted deficiencies in the microbiological laboratory. There was no established written procedure for cleaning incubators, leading to the discovery of mold and mildew in an incubator used for testing U.S.-bound APIs. Furthermore, the laboratory lacked an established written procedure for properly labeling prepared media plates, with current practices omitting crucial details such as analyst initials, inoculation dates, and traceable sample identification.Alps Pharmaceutical is expected to address these issues by implementing robust corrective and preventive actions to ensure the integrity of their data, the cleanliness of their testing environments, and the overall quality and safety of APIs distributed to the United States.