That is quite a statement you make here Rykster.
Ii would be a serious concern if RCE can't meet FDA standards. However, a fault is not necessarily un-fixable. Could be historical documentation was not up to scratch, or old and new samples aren't comparable according to their guidelines, maybe personnel training records are incomplete. All that is fixable (but it'll cost time and money).
But it could be more serious as well. Can you provide proof of your statement? Where/How did RCE go wrong?
You frequently criticise RCE here and make strong statements but you never back them up with real evidence. Come on, be brave and show us your cards.
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