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Thursday, March 24, 2022 8:00:28 PM
There is nothing the FDA can do until UHP can prove capable of producing hemostyp gauze in the new facility exactly as they used in the human trials.
As a result, until they get a line running at Strouse (or wherever they intend to make it now) the FDA can not complete the approval.
The only question the next PR needs to answer is when/where will this happen. Even a small sample run will suffice.
https://www.strouse.com/
UHP is not currently listed as a partner.
In hindsight they now realize they should have left manufacturing in China active until the PMA was complete and then moved it to the US and simply applied for a PMA supplement to get clearance for the move.
These are statements of fact.
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