FDA Inspection 1040452 — SpineSmith Holdings, LLC
The FDA completed an inspection of SpineSmith Holdings, LLC on February 9, 2018 in Austin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |