Dendreon Pharmaceuticals LLC
FDA inspection history in Seal Beach, California, 2019 to 2026
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Seal Beach, California.
- 2019The longest 483 on file: 10 observations over 8 pages at Seal Beach, California.
- 2023One Form 483, at Seal Beach, California.
- 2026One Form 483, at Seal Beach, California.
Cited most
Across all Dendreon Pharmaceuticals observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.42(c)(1)Design and construction features2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.101(d)Charge-in of components1
- 21 CFR 211.113(b)Control of microbiological contamination1
The complete Dendreon Pharmaceuticals file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Seal Beach, California
Three Form 483s · 2019 to 2026 · 21 observations
Latest: Form 483, Mar 25, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-25 | 483 Form 483 | Seal Beach, California | 9 | $99 |
| 2023-08-10 | 483 Form 483 | Seal Beach, California | 2 | $99 |
| 2019-11-08 | 483 Form 483 | Seal Beach, California | 10 | $99 |
Investigators on these documents
Emily B. Camire (1)Esther A. Ofori (1)Latorie S. Jones (1)Lizaida Perez (1)Omotunde O. Osunsanmi (1)Susan M. Jackson (1)
FEI number 3008821247 · most recent document Mar 25, 2026
About Dendreon Pharmaceuticals LLC
How many FDA Form 483s has Dendreon Pharmaceuticals LLC received?
FDA Intel has 3 Form 483s on file for Dendreon Pharmaceuticals LLC; the most recent is dated Mar 25, 2026.
When was Dendreon Pharmaceuticals LLC last inspected by FDA?
The most recent FDA inspection document on file for Dendreon Pharmaceuticals LLC is a Form 483 dated Mar 25, 2026, for the site in Seal Beach, California.
What did FDA cite at Dendreon Pharmaceuticals LLC?
The regulations cited most in the observations on file for Dendreon Pharmaceuticals LLC are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.42(c)(1) (Design and construction features), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.