Extraordinary effort, above and beyond.
If it is proven by review of FDA records that AE (supplier investigation results) information has been withheld which then resulted in patient suffering, which might have been otherwise been prevented/avoided.....WELL IT'S NUCLEAR OPITON TIME AT THE FDA.
We have to wait and see. I have personally been directly involved in some investigations (FOIA) where I had evidence of serious issues in both medical devices and Pharma (including sterile devices) where I could not get the information I knew was there. If this turns up major issues then there is not a hole deep enough to bury them in. In case you have not noticed, money talks.
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