Dendreon Pharmaceuticals LLC
Form 483 issued March 25, 2026 · Seal Beach, California
- Inspection
- Mar 16 – Mar 25, 2026
- Investigators
- Emily B. Camire· Esther A. Ofori· Lizaida Perez
- Observations
- 9
- Pages
- 10
- FEI number
- 3008821247
In short: On March 25, 2026, FDA issued a Form 483 with 9 observations to Dendreon Pharmaceuticals LLC in Seal Beach, California (FEI 3008821247) after an inspection that ran Mar 16 – Mar 25, 2026. The investigators were Emily B. Camire, Esther A. Ofori and Lizaida Perez.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Laboratory records do not include the initials or signature of a second person showing that the…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Emily B. Camire
4 documents · 2023–2026
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in California.
The firmDendreon Pharmaceuticals LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Dendreon Pharmaceuticals LLC?
FDA listed 9 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Dendreon Pharmaceuticals LLC?
Emily B. Camire, Esther A. Ofori and Lizaida Perez are named on this Form 483, for the inspection of Mar 16 – Mar 25, 2026. Each investigator has a profile showing what they cite most.
When was Dendreon Pharmaceuticals LLC inspected by FDA?
The inspection ran Mar 16 – Mar 25, 2026, and the Form 483 is dated March 25, 2026.
How do I get the full Form 483 for Dendreon Pharmaceuticals LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.