# FDA 483 - Abbott Vascular - Unknown Date

Source: https://www.keypedia.com/records/483/abbott-vascular/3634ebda-4086-40b3-b86e-4573dd37e47d

> FDA 483 for Abbott Vascular on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Vascular
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Abbott Vascular in Clonmel, Co. Tipperary, Ireland, identified issues with the validation of their BHT Content test method for stents. The firm's validation protocol and change order for the GCMS sample size were found to lack sufficient justification and did not adequately prove repeatability and reproducibility of the process. This indicates a concern regarding the robustness of their quality control testing.

## Related Officers

- [Sean T. Creighton](https://www.keypedia.com/people/sean-t-creighton/80ffecab-0a2d-4727-a11f-407b697f4503)

Company: https://www.keypedia.com/companies/abbott-vascular/745759b5-fe3d-4e6e-a507-d84e0ed39f35

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd