Company
United StatesBiosense Webster, Inc., Irvine, CA – FDA Inspections
Inspection records and compliance data for Biosense Webster, Inc. in Irvine, California. 2 FDA inspections on record, 1 Form 483, last inspected May 20, 2026.
Company Profile
This profile covers Biosense Webster, Inc. based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 2, 2022. Last inspected May 20, 2026.
Most cited issue areas
- Inadequate monitoring and control over outsourced processes1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 20, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1320444 |
| September 2, 2022 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1180046 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biosense Webster, Inc.
FEI Number
3013300026
Address
31 Technology Dr Ste 200, Irvine, California 92618, United States
Country
United States
ID: 5e71a245-bd54-4d9f-a4d9-ad834f1fa96f