Dendreon Pharmaceuticals LLC
Form 483 issued October 22, 2018 · Union City, Georgia
- Inspection
- Oct 11 – Oct 22, 2018
- Investigator
- Burnell M. Henry
- Observations
- 2
- Pages
- 4
- FEI number
- 3008914686
In short: On October 22, 2018, FDA issued a Form 483 with 2 observations to Dendreon Pharmaceuticals LLC in Union City, Georgia (FEI 3008914686) after an inspection that ran Oct 11 – Oct 22, 2018. The investigator was Burnell M. Henry. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
Observations span 1 system, led by biologics cgmp.
Most cited: 21 CFR 606.100(c) (1×) · 123.7(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
All records pertinent to a lot or unit were not reviewed before the release or distribution…
- 02
You do not have records that document corrective…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
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 606.100(c)
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 biologics CGMP. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected Dendreon Pharmaceuticals LLC?
Burnell M. Henry is named on this Form 483, for the inspection of Oct 11 – Oct 22, 2018. Each investigator has a profile showing what they cite most.
When was Dendreon Pharmaceuticals LLC inspected by FDA?
The inspection ran Oct 11 – Oct 22, 2018, and the Form 483 is dated October 22, 2018.
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.