FDA inspection
Boston Scientific Corporation: FDA inspection ending May 20, 2005
FDA inspection 374321 · Official Action Indicated (OAI) · Quincy, MA
Key facts
| Inspection ID | 374321 |
|---|---|
| Firm | Boston Scientific Corporation |
| FEI number | 3001451463 |
| Address | 500 Commander Shea Blvd |
| City | Quincy |
| State | MA |
| ZIP | 02171-1518 |
| Fiscal year | 2005 |
| Inspection end date | May 20, 2005 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Med Devices |
| Product type | Devices |
| Warning letter | UCM075514 |
At a glance
- 10–99 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