FDA Form 483 Dendreon Corporation Morris Plains, NJ February 2007
Form 483
- Investigators
- Gang Wang· Mary P. Padgett· Thomas P. Finn
- Observations
- 9
- Pages
- 2
In short: FDA issued a Form 483 with 9 observations to FDA Form 483 Dendreon Corporation Morris Plains, NJ February 2007. The investigators were Gang Wang, Mary P. Padgett and Thomas P. Finn. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Observations span 3 systems, led by quality system.
Most cited: 21 CFR 211.25 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no data to support the concurrent manufacturing of lots within…
- 02
Insufficient personnel from the New Jersey manufacturing site were available to perform Aseptic Process Validation in…
- 03
The quality control laboratory did not demonstrate adequate ability to maintain the chain of identity…
- 04
During Day processing on Tuesday, February 13, 2007, we observed that lot number being processed at…
This inspection in context
Gang Wang
1 document
Cites 211.160 (general requirements) more than any other section.
The firmFDA Form 483 Dendreon Corporation Morris Plains, NJ February 2007 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 Dendreon Corporation Morris Plains, NJ February 2007?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 Dendreon Corporation Morris Plains, NJ February 2007?
Gang Wang, Mary P. Padgett and Thomas P. Finn are named on this Form 483. Each investigator has a profile showing what they cite most.
How do I get the full Form 483 for FDA Form 483 Dendreon Corporation Morris Plains, NJ February 2007?
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.