FDA Inspection 1286816 — Dendreon Pharmaceuticals LLC
The FDA completed an inspection of Dendreon Pharmaceuticals LLC on October 29, 2025 in Union City, GA. 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
- October 29, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Union City, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |