FDA Inspection 1290380 — IsoTis OrthoBiologics, Inc.
The FDA completed an inspection of IsoTis OrthoBiologics, Inc. on Oct 17, 2025 in Irvine, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 17, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |