FDA 483 - Abbott Vascular - May 03, 2023

An FDA inspection of Abbott Vascular in Menlo Park, CA, from April 26 to May 3, 2023, revealed significant deficiencies in their quality system. The firm's procedures for rework and continued processing of nonconforming product were found to be inadequate. Specifically, these procedures failed to include provisions for evaluating the adverse effects of such processes on the final product.