FDA 483 - AILEX PHARMACEUTICALS LLC - April 16, 2025

AILEX PHARMACEUTICALS LLC, a corporate headquarters in Lenexa, KS, was inspected regarding its compliance with the Drug Supply Chain Security Act (DSCSA). The inspection revealed a significant failure to implement systems required for DSCSA verification requirements. This includes deficiencies in responding to verification requests, identifying and investigating suspect products, and making necessary notifications to FDA and trading partners.