Company
United StatesDendreon Pharmaceuticals LLC, Seal Beach, CA – FDA Inspections
Inspection records and compliance data for Dendreon Pharmaceuticals LLC in Seal Beach, California. 6 FDA inspections on record, 3 Form 483s, last inspected March 25, 2026.
Company Profile
This profile covers Dendreon Pharmaceuticals LLC based in Seal Beach, California, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected November 15, 2012. Last inspected March 25, 2026.
Most cited issue areas
- Procedures for sterile drug products3 inspections
- Written record of investigation incomplete2 inspections
- Approval and review of procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 25, 2026 | Not classified | Biologics · Human Cellular, Tissue, and Gene Therapies | 1303248 |
| August 10, 2023 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1214688 |
| November 8, 2019 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1109236 |
| January 19, 2018 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1038072 |
| January 22, 2016 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 961300 |
| November 15, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 848259 |
FDA documents
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Dendreon Pharmaceuticals LLC
FEI Number
3008821247
Address
1700 Saturn Way, Seal Beach, California 90740, United States
Country
United States
ID: 68ccd67e-0a3a-41cb-ae30-e9e10a6eaef5