The bigger issue is IF this CMO doesn't get its act together (reg compliance), it could lose its fDA cert to be a CMO...
But as someone who has done 'supplier' qualifying audits, there are all kinds of 'things' that can go wrong..
The question is, what are the 'issues', and are they in the category of, we can't manufacture anything cause we can't be trusted to put out a quality product..
On the other hand, it could be that CRMD is staying one step ahead of the ambulance chasing so called 'legal' firms by being over cautious to not give them any reason to 'sue' (to line their pockets while claiming to care about the little 'shareholders')
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