INSIDE PHARMA

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INSIDE PHARMA
INSIDE PHARMA
FDA must continue to inspect contractors involved in SARS-CoV-2 injections—it's our last bastion of hope

FDA must continue to inspect contractors involved in SARS-CoV-2 injections—it's our last bastion of hope

Quality issues with SARS-CoV-2 injections are mounting

Hedley Rees's avatar
Hedley Rees
Sep 26, 2022
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INSIDE PHARMA
INSIDE PHARMA
FDA must continue to inspect contractors involved in SARS-CoV-2 injections—it's our last bastion of hope
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Quality issues with SARS-CoV-2 injections are mounting

Yesterday, I covered an article in FiercePharma titled: Moderna's new booster launch tripped up by production issues at Catalent plant.

The full account can be found here:

INSIDE PHARMA
FDA unearths a minefield of quality issues at the contractor manufacturing Moderna's jabs
The Achilles' heel of mRNA jabs The Achilles' heel of these mRNA jabs has always been the manufacturing and distribution supply chain. Most people don’t realise it, because they have been conditioned to believe drugs are found by accident, not developed and produced like other consumer products…
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3 years ago · 27 likes · 9 comments · Hedley Rees

The shocking revelation in the article was that there was an extensive catalogue of non-compliances with the legal obligations placed on contractors under the US Code of Federal Regulations, Title 21 (FDA section of CFR)

There should be no ambiguity in this article highlighting major breaches of US law—it’s the Code of Federal Regulations FFS! Nothing trumps them in the US legal world surely?! I’m not a lawyer, but like us all reading this, we have common sense.

This isn’t the first either, check this: J&J finds problem with COVID vaccine batch; NYTimes says 15 million doses ruined

This time it’s J&J and AZ batches ‘conflated’ (mixed together!).

The article comments:

“The Times said that workers had conflated ingredients for the J&J vaccine and a coronavirus vaccine d…

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