FDA inspection
Align Technology Inc: FDA inspection ending Aug 9, 2010
FDA inspection 675562 · Official Action Indicated (OAI) · San Jose, CA
Key facts
| Inspection ID | 675562 |
|---|---|
| Firm | Align Technology Inc |
| FEI number | 3002519584 |
| Address | 2820 Orchard Pkwy |
| City | San Jose |
| State | CA |
| ZIP | 95134 |
| Country | United States |
| Fiscal year | 2010 |
| Inspection end date | Aug 9, 2010 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 134650 |
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
- 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