AILEX PHARMACEUTICALS LLCApril 16, 2025

FDA 483 - AILEX PHARMACEUTICALS LLC - April 16, 2025

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Record Details

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.

Company: AILEX PHARMACEUTICALS LLC
Inspection Date: April 16, 2025
Product Type: Drugs
Office: Kansas City District Office
People: Michele L. Obert (Program Expert )
Eric D. Bowles (Consumer Safety Officer)

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ID · f64b5f8f-8f68-4490-844f-569380a9500a