FDA inspection
CardioFocus, Inc.: FDA inspection ending Aug 11, 2022
FDA inspection 1177544 · Voluntary Action Indicated (VAI) · Marlborough, MA
Key facts
| Inspection ID | 1177544 |
|---|---|
| Firm | CardioFocus, Inc. |
| FEI number | 3001451473 |
| Address | 500 Nickerson Rd Ste 500-200 |
| City | Marlborough |
| State | MA |
| ZIP | 01752 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Aug 11, 2022 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Radiation Control and Health Safety Act |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data