FDA Inspection 1214688 — Dendreon Pharmaceuticals LLC
The FDA completed an inspection of Dendreon Pharmaceuticals LLC on August 10, 2023 in Seal Beach, CA. 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 10, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Seal Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |