FDA Inspection 1072238 — Axogen Corporation
The FDA completed an inspection of Axogen Corporation on November 20, 2018 in Burleson, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 20, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Burleson, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12447 | 21 CFR 1271.290(b) | Establishing a system |