Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-29.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Oct 2025 – 29 Oct 2025 | Biologics | 483 | View 483 → |
| 13 Apr 2022 – 21 Apr 2022 | Biologics | 483 | On file |
| 11 Oct 2018 – 22 Oct 2018 | Biologics | 483 | View 483 → |
| 6 Jan 2015 – 9 Jan 2015 | Biologics | 483 | On file |
| 24 Jun 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Oct 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Brentley S Pittman
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry3 insp.
Brentley S Pittman1 insp.
Brentley S Collins1 insp.
Randa Melhem1 insp.
Priscilla M Pastrana1 insp.
Esra Toussaint1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.7(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Dendreon Pharmaceuticals LLC's 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat