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

An FDA inspection of Alps Pharmaceutical Ind. Co., Ltd. in Hida City, Japan, revealed two significant observations regarding laboratory controls. The firm failed to follow its own QC laboratory procedure for synchronizing instrument times, and its microbiological laboratory lacked written procedures for cleaning incubators and properly labeling prepared media. These deficiencies suggest inadequate control over critical laboratory processes for active pharmaceutical ingredients shipped to the US.