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You're Gonna Need a Bigger Root Cause

Tagin

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#11
There's an interesting article in the NY Times about the issues at Emergent, and based on sound information. Making two products in the same facility is a recipe for mistakes, especially when contamination controls are difficult to implement and not very effective.

U.S. Bet Big on Covid Vaccine Manufacturer Even as Problems Mounted
In their own audit last July, Emergent’s auditors said errors “are not investigated to determine root cause, or are not investigated adequately,” a report stated. “Investigations are terminated without sufficient cause.”
But four former company officials, speaking on the condition of anonymity because they had signed nondisclosure agreements or feared retaliation, described an environment where top Emergent leadership tolerated and even encouraged the flouting of federal standards for manufacturing and marketing products.

Wow.
 
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Mike S.

Happy to be Alive
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#12
I didn't read the article as I don't have an account and don't particularly trust the NYT's reporting. But if true, I hope they (Emergent) pay the price for their willful negligence.

I've seen it happen so often outside of biotech....it would not shock me.
 
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