483
AILEX PHARMACEUTICALS LLCAILEX PHARMACEUTICALS LLC – FDA 483, Apr 16, 2025
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.
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ID · f64b5f8f-8f68-4490-844f-569380a9500a
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