a) What percent of 483s are addressable quickly (e.g. without waiting for a full reinspection (in a month or two))?
I don't have statistics for the industry, but the smallest one I've dealt with personally was in relation to incomplete work instructions for training personnel. While it took less than a day to correct the work instructions, taking it through the process of the corrective and preventative action, internal design review board, validation, internal regulatory, and all the supporting documentation took a total of 1 1/2 months before it was considered done. Then there is the submission to the FDA, and the wait for reply/no reply. Something like this, if caught in an internal audit, would take a week to fix, but when it rises to a 483 everything gets multiplied 3-7 times. Most are easily addressable, but the few that are not take a disproportionally larger amount of time to address. Take a look at DSCO as a good example.
b) Are you involved in NDAs or on-going ops? I would assume that there is a difference in company panic factor depending on whether it is already in production?
I've been involved at all stages, all with small biotechs. No matter the stage, 483s cause extreme panic. But I must say, with a small biotech, 483s at the NDA stage for a first drug/device candidate cause the most panic (and overreaction sometimes) because it really can be a situation of life and death for the company, especially those short on cash with a high burn rate.
Again, DSCO is a good example.
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