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, 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.

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

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ID · c0f89508-84d8-45c1-9457-76c0e87b951e