FDA establishment 3001503333, Irvine, California, United States. Part of IsoTis OrthoBiologics, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
FY2018 to FY2027 to date; 1 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Oct 17, 2025 | Devices · Compliance: Devices | 3 cited references
| Official Action Indicated (OAI) |
| Nov 29, 2017 | Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies | None posted | No Action Indicated (NAI) |
| Sep 25, 2015 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices; Biologics · Human Cellular, Tissue, and Gene Therapies | None posted | No Action Indicated (NAI) |
| Apr 27, 2012 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices; Biologics · Human Cellular, Tissue, and Gene Therapies | None posted | No Action Indicated (NAI) |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters
Irvine, California, United States. Part of