FDA Warning Letter — IsoTis OrthoBiologics, Inc.
The FDA took a Warning Letter action against IsoTis OrthoBiologics, Inc. on February 24, 2026 (Irvine, CA). The action was issued by CDRH and concerns devices products. This facility has 4 recent FDA inspections on record.
Action Details
- Facility
- IsoTis OrthoBiologics, Inc.
- Date
- February 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Center
- CDRH
- Location
- Irvine, CA (United States)