ICON PLCJune 13, 2025

FDA 483 - ICON PLC - June 13, 2025

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Record Details

An FDA inspection of ICON PLC's bioanalytical facility in Lenexa, KS, revealed three significant observations. The firm was cited for using calibration standards and quality control samples beyond their established stability period. Additionally, issues were noted regarding the reporting of reinjected samples due to instrument errors and the reprocessing of subject samples that did not meet acceptance criteria.

Company: ICON PLC
Inspection Date: June 13, 2025
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Sylvestre K. Dossou

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ID · 7cda345e-078a-4dc5-8df8-88a3a91ac8d6