INSIDE PHARMA

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INSIDE PHARMA
INSIDE PHARMA
Rock Solid Evidence that Pfizer's mRNA Manufacturing Facility in Andover was way 'Out of Compliance'

Rock Solid Evidence that Pfizer's mRNA Manufacturing Facility in Andover was way 'Out of Compliance'

Pfizer should never have been allowed to put its products into patient's bodies

Hedley Rees's avatar
Hedley Rees
Jul 30, 2024
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INSIDE PHARMA
INSIDE PHARMA
Rock Solid Evidence that Pfizer's mRNA Manufacturing Facility in Andover was way 'Out of Compliance'
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The Rock Solid Evidence provided by FDA

As subscribers may know, I have been in communication with the FDA’s Center for Biologics Evaluation and Review on the topic of facility inspections that unearthed deep manufacturing issues in facilities producing the SARS-CoV-2 injections drug substance (DS) and drug product (DP). This relates to Pfizer/BioNTech and Moderna.

FDA has been incredibly cooperative, and that is the way I have known them to be ever since me and my company, PharmaFlow, began working with them in 2010.

Yes, through this whole debacle, there has been interference at the top, but the inspectors in the field have still been doing their highly important work identifying issues.

This is what I’ve found out, beginning with a response to my FOIA:

“Dear Mr. Rees,

Thank you for speaking with me earlier today about your Freedom of Information Act (FOIA) request # 2024-5142. Please find attached the FOIA response from the Center for Biologics Evaluation and Research (CBER).

For your co…

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