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FDA confirms that Catalent's war zone inspection results on Moderna boosters did not give grounds to stop them

FDA confirms that Catalent's war zone inspection results on Moderna boosters did not give grounds to stop them

Why has FDA turned soft on manufacturers???

Hedley Rees's avatar
Hedley Rees
Jan 03, 2025
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INSIDE PHARMA
INSIDE PHARMA
FDA confirms that Catalent's war zone inspection results on Moderna boosters did not give grounds to stop them
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You may remember this from last June:

Open letter to Dr Robert Califf, FDA Commissioner: Why were critical quality issues with Moderna boosters, identified by FDA inspectors, ignored?

Open letter to Dr Robert Califf, FDA Commissioner: Why were critical quality issues with Moderna boosters, identified by FDA inspectors, ignored?

Hedley Rees
·
June 9, 2024
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FDA has been very prompt in its response, and as always been the case in my professional experience, they have been very honest and transparent. This is the response:

“Dear Hedley Rees,

Thank you for your inquiry. The Center for Biologics Evaluation and Research (CBER) is one of seven centers within the Food and Drug Administration (FDA). CBER is responsible for the regulation of biologically derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, human cells, tissues, and cellular and tissue-based products (HCT/Ps), gene therapy and xenotransplantation products.   

Your inquiry was forwarded from CBER’s Consumer Affairs Branch to CBER's Manufacturers Assistance and Technical Training Branch (MATTB) for response. We respond to general inquiries from industry. In the future, you may contact us directly at Industry.Biologics@fda.hhs.gov , or 240-402-8020. More on MATTB: https://www.…

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