FDA inspection
Acclarent, Inc.: FDA inspection ending Feb 22, 2013
FDA inspection 817537 · Official Action Indicated (OAI) · Irvine, CA
Key facts
| Inspection ID | 817537 |
|---|---|
| Firm | Acclarent, Inc. |
| FEI number | 3005172759 |
| Address | 31 Technology Dr Suite 200 |
| City | Irvine |
| State | CA |
| ZIP | 92618 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Feb 22, 2013 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 394263 |
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
- 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