Dendreon Corp fka DNDNQ

[iwfal]

issued to Dendreon what is known as an FDA Form 483, Inspectional Observations Report, which cited various violations of FDA regulations at the Dendreon facility.

...

the issuance of a Form 483 made it highly likely that FDA approval would be delayed substantially past May 15, 2007, the anticipated FDA review date

The problem here is that the ambulance chasers are not known to be reliable interpreters of fact. And CMC issues come is a remarkable gradation - from the take-a-week-to-fix to shut--it-down-for-a-year. If the 483 is, as Dendreon suggests inre the approvable letter, a minor one then it wouldn't be 'material' even if they had a 483 ahead of time. I'd be surprised if >50% of first time inspections of new facilities don't result in a 483 - and that most are never reported since they are considered non-material.

BTW - Almost all classes of auditors/inspectors work the same way. They feel they need to report something or they aren't doing anything. That is why it is a very good bet that a very high percentage of CMC inspections find something.