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

An FDA inspection of Alps Pharmaceutical Ind. Co., Ltd. in Hida City, Japan, an Active Pharmaceutical Ingredients Manufacturer, revealed two significant observations. The firm failed to follow established procedures for synchronizing laboratory instrument times and lacked written procedures for cleaning incubators and properly labeling microbiological media plates. These issues indicate deficiencies in quality control and laboratory practices.