# Biosense Webster, Inc. – FDA 483, May 20, 2026

Source: https://www.keypedia.com/records/483/biosense-webster-inc/b6433781-eeb2-47c7-9eaf-ca0454480718

> FDA 483 for Biosense Webster, Inc. on May 20, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biosense Webster, Inc.
- Inspection Date: 2026-05-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/biosense-webster-inc/5e71a245-bd54-4d9f-a4d9-ad834f1fa96f

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6