FDA Inspection 1211189 — SpineSmith Holdings, LLC
The FDA completed an inspection of SpineSmith Holdings, LLC on August 1, 2023 in Austin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 1, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3837 | 21 CFR 820.25(b) | Training records |