FDA inspection
IsoTis OrthoBiologics, Inc.: FDA inspection ending Dec 7, 2004
FDA inspection 354470 · Voluntary Action Indicated (VAI) · Irvine, CA
Key facts
| Inspection ID | 354470 |
|---|---|
| Firm | IsoTis OrthoBiologics, Inc. |
| FEI number | 3001503333 |
| Address | 2 Goodyear Ste A |
| City | Irvine |
| State | CA |
| ZIP | 92618-2052 |
| Fiscal year | 2005 |
| Inspection end date | Dec 7, 2004 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Blood and Blood Products|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices |
| Product type | Biologics, Devices, Drugs |
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
- 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