FDA Inspection
Biosense Webster, Inc.Biosense Webster, Inc. – FDA Inspection, May 20, 2026
Record Details
This FDA Inspection record concerns Biosense Webster, Inc., with an inspection on May 20, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · bcfd9c3d-439e-4cdd-a4d3-7339a9fba601
Inspection Facts
- Inspection number
- 1320444
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
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Other FDA inspections of Biosense Webster, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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