# IsoTis OrthoBiologics, Inc. - Inspection Records

Source: https://www.keypedia.com/companies/isotis-orthobiologics-inc/df4a7da7-92c2-474d-b810-2ad643c54425

> Inspection records and compliance data for IsoTis OrthoBiologics, Inc. in Irvine, California. Access full analysis and detailed observations.

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## Details

- Name: IsoTis OrthoBiologics, Inc.
- FEI Number: 3001503333
- City: Irvine
- State: California
- Country Name: United States
- Address Line 1: 2 Goodyear Ste A
- Zip Code: 92618

## Related Documents

- [483 - IsoTis OrthoBiologics, Inc. - 2026-03-06](https://www.keypedia.com/records/483/isotis-orthobiologics-inc/ba2d0b4c-4133-420a-bac9-4bcbdcf44623) — source: FDA, date: March 6, 2026
- [483 - IsoTis OrthoBiologics, Inc. - 2026-03-06](https://www.keypedia.com/records/483/isotis-orthobiologics-inc/ded7ad85-8b9c-44e0-9843-7e371b7c3344) — source: FDA, date: March 6, 2026
- [FDA Inspection 1306970 - IsoTis OrthoBiologics, Inc. - 2026-03-06](https://www.keypedia.com/records/fda_inspections/isotis-orthobiologics-inc/bd6ba2f2-55e8-4d26-be9d-3ca1afe19b9f) — source: FDA, date: March 6, 2026
- [WARNING_LETTER - IsoTis OrthoBiologics, Inc. - 2025-10-17](https://www.keypedia.com/records/warning_letter/isotis-orthobiologics-inc/916c2859-5b32-4196-8262-318254949828) — source: FDA, date: October 17, 2025
- [FDA Inspection 1290380 - IsoTis OrthoBiologics, Inc. - 2025-10-17](https://www.keypedia.com/records/fda_inspections/isotis-orthobiologics-inc/5ef63c88-91ba-4d6f-acd0-719075388556) — classification: Official Action Indicated (OAI), source: FDA, date: October 17, 2025
- [FDA Inspection 1290380 - IsoTis OrthoBiologics, Inc. - 2025-10-17](https://www.keypedia.com/records/fda_inspections/isotis-orthobiologics-inc/86c45f70-825e-4a34-87e2-9491e260158f) — classification: Official Action Indicated (OAI), source: FDA, date: October 17, 2025
- [FDA Inspection 1033932 - IsoTis OrthoBiologics, Inc. - 2017-11-29](https://www.keypedia.com/records/fda_inspections/isotis-orthobiologics-inc/bf521d0f-a203-409a-9eea-5b238a14f34d) — classification: No Action Indicated (NAI), source: FDA, date: November 29, 2017
- [FDA Inspection 1033932 - IsoTis OrthoBiologics, Inc. - 2017-11-29](https://www.keypedia.com/records/fda_inspections/isotis-orthobiologics-inc/44d260ab-a308-46f0-99a9-f5d5f36bd4a3) — classification: No Action Indicated (NAI), source: FDA, date: November 29, 2017
- [FDA Inspection 942796 - IsoTis OrthoBiologics, Inc. - 2015-09-25](https://www.keypedia.com/records/fda_inspections/isotis-orthobiologics-inc/6fc3cf21-41f3-4e39-ab06-12e68f5e4a5c) — classification: No Action Indicated (NAI), source: FDA, date: September 25, 2015
- [FDA Inspection 942796 - IsoTis OrthoBiologics, Inc. - 2015-09-25](https://www.keypedia.com/records/fda_inspections/isotis-orthobiologics-inc/b96aa43e-ccb4-4b56-a17d-1342218e6494) — classification: No Action Indicated (NAI), source: FDA, date: September 25, 2015
- [FDA Inspection 942796 - IsoTis OrthoBiologics, Inc. - 2015-09-25](https://www.keypedia.com/records/fda_inspections/isotis-orthobiologics-inc/abbfe4b4-819f-474f-ba03-4af75929c20a) — classification: No Action Indicated (NAI), source: FDA, date: September 25, 2015
- [FDA Inspection 777655 - IsoTis OrthoBiologics, Inc. - 2012-04-27](https://www.keypedia.com/records/fda_inspections/isotis-orthobiologics-inc/65d93bff-a1a2-4452-a598-d070dd166c22) — classification: No Action Indicated (NAI), source: FDA, date: April 27, 2012
- [FDA Inspection 777655 - IsoTis OrthoBiologics, Inc. - 2012-04-27](https://www.keypedia.com/records/fda_inspections/isotis-orthobiologics-inc/a096089f-693c-4c67-99de-5d740a6e1ea8) — classification: No Action Indicated (NAI), source: FDA, date: April 27, 2012

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## Related Officers

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- [Acting Director](https://www.keypedia.com/people/barbara-a-marsden/985d635d-6ed5-4512-bc3e-c3aedca2be7d)
- [Melsomar R. Ramos](https://www.keypedia.com/people/melsomar-r-ramos/395e7ddc-ed98-455a-a143-0ee5f46804f4)
