FDA Inspection 1070321 — Dendreon Pharmaceuticals LLC
The FDA completed an inspection of Dendreon Pharmaceuticals LLC on October 22, 2018 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 22, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Union City, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 932 | 21 CFR 123.7(d) | Corrective action documentation |