FDA inspection
Cardiac Assist, Inc: FDA inspection ending Feb 7, 2014
FDA inspection 863382 · Official Action Indicated (OAI) · Pittsburgh, PA
Key facts
| Inspection ID | 863382 |
|---|---|
| Firm | Cardiac Assist, Inc |
| FEI number | 3002228812 |
| Address | 240 Alpha Dr |
| City | Pittsburgh |
| State | PA |
| ZIP | 15238 |
| Country | United States |
| Fiscal year | 2014 |
| Inspection end date | Feb 7, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 424250 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 10–99 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