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From a manufacturer friend in NY who is trying to import PPE and buy a machine that makes FDA-approved surgical masks. She says she could have imported 100s of 1000s of PPE items weeks ago and started making up to 10K masks a week but has been hitting a wall with FDA restrictions
She is not the only manufacturer facing this problem with the FDA while trying to manufacture or import PPE.
Cuomo is begging people with the capacity to make PPE to contribute, so why are they facing such hurdles from the FDA at a time of such incredible crisis?
Of course PPE needs to pass inspection to prove it is viable for hospital use, but buying an FDA-approved machine to make FDA-approved masks should not take 3 months right now. There has to be a way to speed things up. So many people are dying and we’re not even at peak yet.
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