FDA inspection
Biostructures, LLC: FDA inspection ending May 17, 2010
FDA inspection 663713 · Voluntary Action Indicated (VAI) · Newport Beach, CA
Key facts
| Inspection ID | 663713 |
|---|---|
| Firm | Biostructures, LLC |
| FEI number | 3005449756 |
| Address | 1201 Dove St Ste 470 |
| City | Newport Beach |
| State | CA |
| ZIP | 92660 |
| Country | United States |
| Fiscal year | 2010 |
| Inspection end date | May 17, 2010 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 113928 |
At a glance
- None 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