3 ms·
> The government doesn't give you "feedback." http://www.fda.gov/ICECI/Inspections/ucm256377.htm http://www.fda.gov/ICECI/Inspections/ucm256377.htm > when
by peteretep 11y ago
> The government doesn't give you "feedback."
http://www.fda.gov/ICECI/Inspections/ucm256377.htm http://www.fda.gov/ICECI/Inspections/ucm256377.htm
> when an investigator(s) has observed any conditions
> that in their judgement may constitute violations
Sure sounds like feedback to me.
> The process documentation and design specification
> and validation issues are not optional
No, but they can be iterated on.
> I am taking the fine article at face value
The "fine article" presents small snippets of a heavily redacted article. There's not that much value to take...