Company
United StatesSaphena Medical, Inc., West Bridgewater, MA – FDA Inspections
Inspection records and compliance data for Saphena Medical, Inc. in West Bridgewater, Massachusetts. 1 FDA inspection on record, last inspected March 04, 2025.
Company Profile
This profile covers Saphena Medical, Inc. based in West Bridgewater, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected March 4, 2025.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 4, 2025 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1262841 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Saphena Medical, Inc.
FEI Number
3011171776
Address
375 West St, West Bridgewater, Massachusetts 02379, United States
Country
United States
ID: 75a2eb98-8419-4882-b370-e72e2bfd48f8