Who chose the mfg'er? Who didn't keep close enough tabs on them to ensure their practices would meet FDA standards? The mfg doesn't operate in a vacuum, ya know? At least it SHOULDN'T. Rumor has it that NAVB pulled a MNKD type mistake here, as in changing part of mfg process or delivery device to either save money or whatever, as in different from what they submitted in the original NDA or used in the drug trials - that's idiotic if true! Guess we'll have to wait and see what exactly the issue was at the next quarterly CC - hopefully earlier if the FDA can get inspectors back there quickly - not likely, as the most overburdened part of the FDA is the inspection side.
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