Sanofi FDA warning letter

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anonymous said:
Just published on fda website today
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Interesting reading. What’s not visible unless you know is it’s the same drugs that were impacted by the consent decree a few years back. And head of quality was also very actively a significant part of that consent decree quality team too. But you can read the place is a disaster and it’s not wrong. Understaffed. Not learning lessons. Place is out of control. Perhaps another CD coming ?
 






Attrition. Everywhere. Learning gaps. Everywhere. There IS a price to pay for the global cost/people cutting. Impacting all phases, but only hearing of this mess because FDA inspected. If they looked behind Sanofi curtains anywhere, any department right now they’d see the mess.
 






anonymous said:
Attrition. Everywhere. Learning gaps. Everywhere. There IS a price to pay for the global cost/people cutting. Impacting all phases, but only hearing of this mess because FDA inspected. If they looked behind Sanofi curtains anywhere, any department right now they’d see the mess.
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Driven by McKinsey processes. Look what happened to Boeing when they followed they same path…
 






Perhaps the FDA and other regulators should look at the headcount over the last few years. It’s been declining and as always the company runs to the bank with the savings before they are realized. Means they have too few staff for the processes and oversight. And the newly developed processes etc cut too many corners because the changes are driven by the so called $ savings which are more than negated when the sites get hit with warning letters etc. so many sites are in a state of shambles it’s ridiculous. FDA should go in and inspect them all. Consent decree here we come. My guess is Framingham will also be closed.
 












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