# FDA 483 - AILEX PHARMACEUTICALS LLC - April 16, 2025

Source: https://www.keypedia.com/records/483/ailex-pharmaceuticals-llc/f64b5f8f-8f68-4490-844f-569380a9500a

> FDA 483 for AILEX PHARMACEUTICALS LLC on April 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AILEX PHARMACEUTICALS LLC
- Inspection Date: 2025-04-16
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: 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.

## Related Officers

- [Program Expert ](https://www.keypedia.com/people/michele-l-obert/7ac8155e-cc5a-4e89-a885-c68ce69adb4e)
- [Consumer Safety Officer](https://www.keypedia.com/people/eric-d-bowles/bb6c783b-0933-4231-b79e-c591cbc50104)

Company: https://www.keypedia.com/companies/ailex-pharmaceuticals-llc/88b18998-66d3-4f34-b8bf-264ad98290c9

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79