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Re: mouton29 post# 1651

Monday, 11/09/2020 8:02:35 PM

Monday, November 09, 2020 8:02:35 PM

Post# of 7360
I have to admit, I’m surprised with the lack of guidance from the FDA apropos the delay in auditing the manufacturing site. Are we looking at 3 months, 6 months or 12 months delay? Strikes me odd that there was “supposedly” no communication from the FDA on guidance for this required action item.
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