FDA inspection
Thoratec LLC: FDA inspection ending Sep 7, 2011
FDA inspection 741711 · Voluntary Action Indicated (VAI) · Pleasanton, CA
Key facts
| Inspection ID | 741711 |
|---|---|
| Firm | Thoratec LLC |
| FEI number | 2916596 |
| Address | 6035 Stoneridge Dr |
| City | Pleasanton |
| State | CA |
| ZIP | 94588 |
| Country | United States |
| Fiscal year | 2011 |
| Inspection end date | Sep 7, 2011 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 248634 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No 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