# FDA 483 - ICON plc - October 24, 2025

Source: https://www.keypedia.com/records/483/icon-plc/c0f89508-84d8-45c1-9457-76c0e87b951e

> FDA 483 for ICON plc on October 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ICON plc
- Inspection Date: 2025-10-24
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of ICON plc's bioanalytical facility in Assen, Netherlands, identified a significant issue with method validation. The firm failed to adequately evaluate the specificity of bioanalytical methods for certain compounds in the presence of all co-administered medications. This indicates a potential deficiency in the rigor of their method validation processes.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/sri-rama-krishnaiah-yellela/9cf2e148-03b3-4e6a-b878-6dee15f651a6)

Company: https://www.keypedia.com/companies/icon-plc/5878cba4-8fce-4e54-9079-aa539a3a9403

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917