Biosense Webster, Inc. – FDA 483, May 20, 2026
An FDA inspection of Biosense Webster, Inc. in Irvine, CA, identified a significant issue regarding the control of outsourced manufacturing processes. The firm's contract manufacturer for the Class II Carto Vizigo 8.5F Bi-Directional Guiding Sheath failed to adequately document the verification of rework processes for nonconforming products. This lapse means the firm cannot confirm that reworked devices meet validated or verified process requirements, indicating a breakdown in quality agreement compliance.
ID · b6433781-eeb2-47c7-9eaf-ca0454480718
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