Company
United StatesSpirus Medical, LLC, West Bridgewater, MA – FDA Inspections
Inspection records and compliance data for Spirus Medical, LLC in West Bridgewater, Massachusetts. 3 FDA inspections on record, last inspected November 18, 2022.
Company Profile
This profile covers Spirus Medical, LLC based in West Bridgewater, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 8, 2012. Last inspected November 18, 2022.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 18, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1190817 |
| June 6, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1055653 |
| February 8, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 766719 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Spirus Medical, LLC
FEI Number
3005814162
Address
375 West St, West Bridgewater, Massachusetts 02379, United States
Country
United States
ID: e066bbff-5c45-424c-a35a-2f2c1c54e483