FDA inspection
Aurora Healthcare US Corp: FDA inspection ending Sep 23, 2004
FDA inspection 346405 · Official Action Indicated (OAI) · Danvers, MA
Key facts
| Inspection ID | 346405 |
|---|---|
| Firm | Aurora Healthcare US Corp |
| FEI number | 3000717812 |
| Address | 9b Electronics Ave |
| City | Danvers |
| State | MA |
| ZIP | 01923-1008 |
| Fiscal year | 2004 |
| Inspection end date | Sep 23, 2004 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Med 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