Dendreon Pharmaceuticals LLC
Form 483 issued November 8, 2019 · Seal Beach, California
- Inspection
- Oct 28 – Nov 8, 2019
- Investigator
- Omotunde O. Osunsanmi
- Observations
- 10
- Pages
- 8
- FEI number
- 3008821247
In short: On November 8, 2019, FDA issued a Form 483 with 10 observations to Dendreon Pharmaceuticals LLC in Seal Beach, California (FEI 3008821247) after an inspection that ran Oct 28 – Nov 8, 2019. The investigator was Omotunde O. Osunsanmi. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 8 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
The batch production and control records are deficient in that they do not include a statement…
- 02
Written procedures are not reviewed and approved by…
- 03
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Omotunde O. Osunsanmi
13 documents · 2003–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in United Kingdom.
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 211.188(b)(7)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dendreon Pharmaceuticals LLC?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Dendreon Pharmaceuticals LLC?
Omotunde O. Osunsanmi is named on this Form 483, for the inspection of Oct 28 – Nov 8, 2019. Each investigator has a profile showing what they cite most.
When was Dendreon Pharmaceuticals LLC inspected by FDA?
The inspection ran Oct 28 – Nov 8, 2019, and the Form 483 is dated November 8, 2019.
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.