FDA Inspection 754612 — Unified Spine, Llc
The FDA completed an inspection of Unified Spine, Llc on November 18, 2011 in Westerville, OH. 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
- November 18, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Westerville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3323 | 21 CFR 820.170(b) | Installer records |