FDA inspection
Cardiac Designs Inc.: FDA inspection ending Jun 29, 2016
FDA inspection 976041 · Voluntary Action Indicated (VAI) · Round Rock, TX
Key facts
| Inspection ID | 976041 |
|---|---|
| Firm | Cardiac Designs Inc. |
| FEI number | 3010665082 |
| Address | 1104 S Mays St Ste 219 |
| City | Round Rock |
| State | TX |
| ZIP | 78664 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Jun 29, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| 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