ICON plcOctober 24, 2025

FDA 483 - ICON plc - October 24, 2025

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Record Details

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.

Company: ICON plc
Inspection Date: October 24, 2025
Product Type: Drugs
Office: Division of Blood Components and Devices
People: Sri Rama Kr Yellela
Sri Rama Krishnaiah Yellela (issuing_officer)

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ID · 7cb74697-beea-47f5-926a-54f82ffc142d