Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-25.
At a glance
Inspections
6
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 25 Mar 2026 | Biologics | 483 | View 483 → |
| 2 Aug 2023 – 10 Aug 2023 | Biologics | 483 | View 483 → |
| 28 Oct 2019 – 8 Nov 2019 | Biologics | 483 | View 483 → |
| 9 Jan 2018 – 19 Jan 2018 | Biologics | 483 | View 483 → |
| 14 Jan 2016 – 22 Jan 2016 | Biologics | 483 | On file |
| 8 Apr 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Mar 2026
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Sony Mathews, Esther A Ofori, Emily B Camire, Lizaida Perez
25 Mar 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Sony Mathews, Esther A Ofori, Emily B Camire, Lizaida Perez
25 Mar 2026
21 CFR 211.115(b)
Reprocessing/quality control unit
Cited by Sony Mathews, Esther A Ofori, Emily B Camire, Lizaida Perez
25 Mar 2026
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Sony Mathews, Esther A Ofori, Emily B Camire, Lizaida Perez
25 Mar 2026
21 CFR 211.192
Written record of investigation incomplete
Cited by Sony Mathews, Esther A Ofori, Emily B Camire, Lizaida Perez
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry2 insp.
Sony Mathews1 insp.
Esther A Ofori1 insp.
Emily B Camire1 insp.
Lizaida Perez1 insp.
Susan M Jackson1 insp.
Latorie S Jones1 insp.
Omotunde O Osunsanmi1 insp.
Arie Menachem1 insp.
Mihaly S Ligmond1 insp.
Priscilla M Pastrana1 insp.
Gang Wang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 600.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Dendreon Pharmaceuticals LLC's 6 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