Dendreon Pharmaceuticals LLC
Form 483 issued August 10, 2023 · Seal Beach, California
- Inspection
- Aug 2 – Aug 10, 2023
- Investigators
- Latorie S. Jones· Susan M. Jackson
- Observations
- 2
- Pages
- 6
- FEI number
- 3008821247
In short: On August 10, 2023, FDA issued a Form 483 with 2 observations to Dendreon Pharmaceuticals LLC in Seal Beach, California (FEI 3008821247) after an inspection that ran Aug 2 – Aug 10, 2023. The investigators were Latorie S. Jones and Susan M. Jackson. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.84(e) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 02
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
The firmDendreon Pharmaceuticals LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dendreon Pharmaceuticals LLC?
FDA listed 2 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Dendreon Pharmaceuticals LLC?
Latorie S. Jones and Susan M. Jackson are named on this Form 483, for the inspection of Aug 2 – Aug 10, 2023. Each investigator has a profile showing what they cite most.
When was Dendreon Pharmaceuticals LLC inspected by FDA?
The inspection ran Aug 2 – Aug 10, 2023, and the Form 483 is dated August 10, 2023.
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.