FDA Inspection 1302634 — SpineSmith Holdings, LLC
The FDA completed an inspection of SpineSmith Holdings, LLC on February 13, 2026 in Austin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23089 | ISO 13485:2016 Clause 7.1 | Required elements not determined in planning product realization |
| 23150 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities not established or implemented |