Company
United StatesCardioFocus, Inc., Marlborough, MA – FDA Inspections
Inspection records and compliance data for CardioFocus, Inc. in Marlborough, Massachusetts. 5 FDA inspections on record, 1 Form 483, last inspected August 11, 2022.
Company Profile
This profile covers CardioFocus, Inc. based in Marlborough, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected September 23, 2011. Last inspected August 11, 2022.
Most cited issue areas
- Complaints1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 11, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1177544 |
| June 30, 2017 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1016613 |
| May 7, 2015 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 928695 |
| November 28, 2012 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 808977 |
| September 23, 2011 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 746966 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
CardioFocus, Inc.
FEI Number
3001451473
Address
500 Nickerson Rd Ste 500-200, Marlborough, Massachusetts 01752, United States
Country
United States
ID: 49750a9c-aa39-4080-bfaa-4edc4912b956