FDA inspection
IsoTis OrthoBiologics, Inc.: FDA inspection ending Jun 3, 2008
FDA inspection 521004 · No Action Indicated (NAI) · Irvine, CA
Key facts
| Inspection ID | 521004 |
|---|---|
| Firm | IsoTis OrthoBiologics, Inc. |
| FEI number | 3001503333 |
| Address | 2 Goodyear Ste A |
| City | Irvine |
| State | CA |
| ZIP | 92618-2052 |
| Fiscal year | 2008 |
| Inspection end date | Jun 3, 2008 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med 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Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene 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Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: 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
- None Citations
- None 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