# FDA 483 - ICON PLC - June 13, 2025

Source: https://www.globalkeysolutions.net/records/483/icon-plc/7cda345e-078a-4dc5-8df8-88a3a91ac8d6

> FDA 483 for ICON PLC on June 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ICON PLC
- Inspection Date: 2025-06-13
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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.

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## Related Officers

- [Sylvestre K. Dossou](https://www.globalkeysolutions.net/people/sylvestre-k-dossou/962f9277-7643-4f66-add9-1c3553fa1c14)

Company: https://www.globalkeysolutions.net/companies/icon-plc/c13f8578-b276-46b7-a484-c5b6b699e71f

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c