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boi568

10/08/20 10:15 AM

#274548 RE: XenaLives #274539

Not to me.

nidan7500

10/08/20 10:45 AM

#274562 RE: XenaLives #274539

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

Xena

Kinda makes COVID look like small potatoes, doesn't it?



yes, that is exactly correct. The corrective actions plans (see link above) being taken by FDA is a cop-out, IMO. They are saying..."Hey, shat happens and we got this virus to deal with". So getting a vaccine is what we do,(that is how we fix it) and it will be done according to the FDA rules. No statement on what caused it.

Anyone asking what caused the virus to occur and to prove it was the cause and what steps are being taken to ensure required monitors and controls are established to prevent recurrences? That is basic problem solving 101 . In fact if the FDA-CDC-WHO were being honest they would write themselves a form 483 (non conformance) for not properly identifying the root cause and for taking appropriate follow up (required by LAW) ACTIONS.

ZERO stones being shown here by the regulatory body. Keep in mind this is only the most recent example. We have wide systems evidence that the FDA monitors and control are completely inadequate.

Like I said this is basic engineering/Quality management systems 101, see 21 CFR part 820 and numerous ISO-EA requirements for same thing.

Our medical systems are a joke, CV19 is only the most recent example.