FDA Inspection 843894 — XTANT Medical Holdings, Inc
The FDA completed an inspection of XTANT Medical Holdings, Inc on August 2, 2013 in Belgrade, MT. 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
- August 2, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Belgrade, MT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |