# FDA 483 - ICON PLC - June 13, 2025

Source: https://www.keypedia.com/records/483/icon-plc/e630c682-4dfc-4830-9d1d-0a466fb3e90a

> 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: FDA District Office — White Oak, Maryland
- Summary: 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.

## Related Documents

- [483 - 2025-06-13](https://www.keypedia.com/records/483/icon-plc/7cda345e-078a-4dc5-8df8-88a3a91ac8d6)
- [483 - 2025-10-24](https://www.keypedia.com/records/483/icon-plc/9700580f-924b-4397-a047-359d39101036)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/fda-district-office-white-oak-maryland/c6b6b27d-a39a-40fa-83a6-f32af5017c37