FDA Inspection 997755 — Nexxt Spine, LLC
The FDA completed an inspection of Nexxt Spine, LLC on December 30, 2016 in Noblesville, IN. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 30, 2016
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Noblesville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12322 | 21 CFR 1271.160(b)(4) | Training of personnel |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |