I respect what you write but this may not be true though. I remember seeing a few companies, who had overseas manufacturing units. FDA inspect them as a part of the application process.
In general that is true.
But NWBO has stated in SEC docs they need regional manufacturing because the leuko is shipped unfrozen and has a short lifespan.
I'm not saying foreign manufacturing is the reason, I don't believe that 20 tiny cleanrooms would constitute commercial production for the US. When the EDEN Units are employed in a large cleanroom in Sawston they will qualify.