Actually - judging by freely available guidelines and SOPPs it is reasonable to say it is you who is overestimating inefficiencies the FDA workflow.Your bias in interpretating texts ignores basic language such as the FDA not scheduling a PLI if they think there are significant deficiencies in their application.
You argue against what constitutes significant and then you argue what will be significant as though the FDA somehow lacks foresight in their own dealings.
It is clear that you think there deficiencies , but you think there are deficiencies in everything MSB.
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-267
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