FDA Inspection 1272883 — EnduroMed
The FDA completed an inspection of EnduroMed on June 17, 2025 in Brookfield, WI. 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
- June 17, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Brookfield, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |