Dendreon Pharmaceuticals

Seal Beach, California, United States
Hybrid — also manufactures internal programs
Cell & Gene Therapy
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Dendreon Pharmaceuticals

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Seal Beach, California, United States
Website
Modalities
Cell & Gene Therapy
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About Dendreon Pharmaceuticals

Dendreon Pharmaceuticals makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Cell & Gene Therapy. 2 manufacturing sites registered with the U.S. FDA. Website: https://www.dendreon.com/science-and-services/cell-therapy-manufacturing/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

Dendreon Pharmaceuticals FDA Inspection History

2025-10
2023-08
2022-04
NAI VAI OAI
Date Site Type Observations Classification
2025-10-29
Dendreon Pharmaceuticals LLC
Union City, Georgia Company-level
Human Cellular, Tissue, and Gene Therapies Yes Voluntary Action Indicated (VAI)
2023-08-10
Dendreon Pharmaceuticals LLC
Seal Beach, California Company-level
Human Cellular, Tissue, and Gene Therapies Yes Voluntary Action Indicated (VAI)
2022-04-21
Dendreon Pharmaceuticals LLC
Union City, Georgia Company-level
Human Cellular, Tissue, and Gene Therapies No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Dendreon Pharmaceuticals FDA 483 Findings 4 observations · 2023-08-10 → 2025-10-29 ?

By subsystem

  • Documentation & Records 2 (50.0%)
  • Laboratory Controls 1 (25.0%)
  • CAPA 1 (25.0%)

By severity

  • 3 — Moderate: 2
  • 2 — Minor: 2
  • Repeat observations: 0

Most severe findings

  • Moderate (3) Laboratory Controls 2025-10-29 21 CFR 211.194(a)
    Complete test data included in records

    "Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards."

  • Moderate (3) CAPA 2023-08-10 21 CFR 211.192
    Extent of discrepancy, failure investigations

    "Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product."

  • Minor (2) Documentation & Records 2025-10-29 21 CFR 211.110(a)
    Control procedures to monitor and validate performance

    "Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product."

About this data →

Hiring Activity Beta

Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data. This company's careers site asks automated readers not to collect it (robots.txt), and we respect that.
Source: public careers pages · Checked Oct 30, 2026

Frequently Asked Questions About Dendreon Pharmaceuticals

How many FDA inspections does Dendreon Pharmaceuticals have on record?
CDMO Signal tracks 3 FDA inspections for Dendreon Pharmaceuticals, sourced from the FDA inspection database. See the full inspection history above.
Has Dendreon Pharmaceuticals received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Dendreon Pharmaceuticals.
Does Dendreon Pharmaceuticals have a CDMO Signal Score?
Not yet. Dendreon Pharmaceuticals is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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