FDA inspection
Access CardioSystems: FDA inspection ending Nov 5, 2004
FDA inspection 354301 · Voluntary Action Indicated (VAI) · Concord, MA
Key facts
| Inspection ID | 354301 |
|---|---|
| Firm | Access CardioSystems |
| FEI number | 3003585458 |
| Address | 2352 Main St Ste 104 |
| City | Concord |
| State | MA |
| ZIP | 01742-3836 |
| Fiscal year | 2005 |
| Inspection end date | Nov 5, 2004 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Med Devices |
| Product type | Devices |
At a glance
- None 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