FDA Inspection 1306782 — Xtent BioMedical LLC
The FDA completed an inspection of Xtent BioMedical LLC on March 5, 2026 in Bartlett, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 5, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Bartlett, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |