# FDA WARNING_LETTER - IsoTis OrthoBiologics, Inc. - October 17, 2025

Source: https://www.globalkeysolutions.net/records/warning_letter/isotis-orthobiologics-inc/916c2859-5b32-4196-8262-318254949828

> FDA WARNING_LETTER for IsoTis OrthoBiologics, Inc. on October 17, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: IsoTis OrthoBiologics, Inc.
- Inspection Date: 2025-10-17
- Product Type: devices
- Office Name: Office of Regulatory Programs

## Related Officers

- [Acting Director](https://www.globalkeysolutions.net/people/barbara-a-marsden/985d635d-6ed5-4512-bc3e-c3aedca2be7d)
- [Peter P. Nalbach](https://www.globalkeysolutions.net/people/peter-p-nalbach/d65f47f9-0914-4ddf-8dc7-3e6d3b32c7e3)

Company: https://www.globalkeysolutions.net/companies/isotis-orthobiologics-inc/df4a7da7-92c2-474d-b810-2ad643c54425

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-programs/50a60a22-777e-46af-b7a9-08831f91d672