Dendreon Pharmaceuticals LLC
Form 483 issued April 21, 2022 · Union City, Georgia
- Inspection
- Apr 13 – Apr 21, 2022
- Investigators
- Brentley Collins· Burnell M. Henry
- Observations
- 3
- Pages
- 4
- FEI number
- 3008914686
In short: On April 21, 2022, FDA issued a Form 483 with 3 observations to Dendreon Pharmaceuticals LLC in Union City, Georgia (FEI 3008914686) after an inspection that ran Apr 13 – Apr 21, 2022. The investigators were Brentley Collins and Burnell M. Henry. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Calibration equipment used to standardize instruments, apparatus, gauges, and recording devices do not meet limits for…
- 02
Written records of investigations into the failure of a batch or any of its components to…
- 03
Not all product complaints are closed and extensions for investigations requested in the required timeframes established…
This inspection in context
Brentley Collins
11 documents · 2019–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dendreon Pharmaceuticals LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Dendreon Pharmaceuticals LLC?
Brentley Collins and Burnell M. Henry are named on this Form 483, for the inspection of Apr 13 – Apr 21, 2022. Each investigator has a profile showing what they cite most.
When was Dendreon Pharmaceuticals LLC inspected by FDA?
The inspection ran Apr 13 – Apr 21, 2022, and the Form 483 is dated April 21, 2022.
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.