FDA 483 - Abbott Vascular

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.