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483
•ICON PLC•June 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 observations. The firm was cited for using calibration standards and QC samples beyond their established stability period. Additionally, issues were noted regarding the reporting of reinjected samples due to instrument errors and the failure to report reprocessed samples.

Company
ICON PLC
Inspection Date
June 13, 2025
Product Type
Drugs
Office
FDA District Office — White Oak, Maryland
Person
  • Sylvestre K. Dossou
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ID · e630c682-4dfc-4830-9d1d-0a466fb3e90a

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