Dendreon Pharmaceuticals LLC
Form 483 issued January 9, 2015 · Union City, Georgia
- Inspection
- Jan 6 – Jan 9, 2015
- Observations
- 2
- Pages
- 2
- FEI number
- 3008914686
In short: On January 9, 2015, FDA issued a Form 483 with 2 observations to Dendreon Pharmaceuticals LLC in Union City, Georgia (FEI 3008914686) after an inspection that ran Jan 6 – Jan 9, 2015. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (1×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Corrective actions to prevent training investigation exception…
This inspection in context
Questions about this 483
What did FDA find at Dendreon Pharmaceuticals LLC?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
When was Dendreon Pharmaceuticals LLC inspected by FDA?
The inspection ran Jan 6 – Jan 9, 2015, and the Form 483 is dated January 9, 2015.
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.