I dedicated some time of my work life on FDA compliance. Generally FDA gives the observations to company first & later it is uploaded. In all faireness no company gives details of observations. They just mention # of observations which Natco has already done that.
Coming to observations, couple of observations looks serious. But it all depends on how good is their response to these observations. My personal view is that this will be an overhang for sometime and restrict its upside for sometime.
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