# FDA 483 - ICON plc - October 24, 2025

Source: https://www.keypedia.com/records/483/icon-plc/7cb74697-beea-47f5-926a-54f82ffc142d

> 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, revealed a significant deficiency in method validation activities. The firm failed to adequately evaluate the specificity of bioanalytical methods for certain compounds in the presence of all co-administered medications during a study. This indicates a potential issue with the reliability of the analytical data.

## Related Officers

- [Sri Rama Kr Yellela](https://www.keypedia.com/people/sri-rama-kr-yellela/b579e7ba-855b-4a15-b0fb-35bf33562d09)
- [issuing_officer](https://www.keypedia.com/people/sri-rama-krishnaiah-yellela/9cf2e148-03b3-4e6a-b878-6dee15f651a6)

Company: https://www.keypedia.com/companies/icon-plc/a2285af4-5657-47fc-881c-639cfcd1ff23

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