INSIDE PHARMA

INSIDE PHARMA

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INSIDE PHARMA
INSIDE PHARMA
FDA provides Hedley with Establishment Inspection Report FEI: 1222181: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, Andover, MA.

FDA provides Hedley with Establishment Inspection Report FEI: 1222181: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, Andover, MA.

Now we are getting into the nitty gritty! Come join me on a journey into FDA land

Hedley Rees's avatar
Hedley Rees
Jun 18, 2024
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INSIDE PHARMA
INSIDE PHARMA
FDA provides Hedley with Establishment Inspection Report FEI: 1222181: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, Andover, MA.
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Note to subscribers

You may remember this from a few days ago:

FDA freedom of information request on inspections carried out on Pfizer's Wyeth Biopharma

FDA freedom of information request on inspections carried out on Pfizer's Wyeth Biopharma

Hedley Rees
·
June 14, 2024
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I have received a response to the FOIA from Elizabeth Sly at FDA:

Center for Biologics Evaluation and Research (CBER)
Access Litigation and Freedom of Information Branch
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Building 71, Room 1114
Silver Spring, MD 20993-0002

Not only that, but she called me yesterday to make sure that I understood the various links to reports that are available in searches on the FDA website. I had asked for the request to be given fast-track status, due to the potential for harm to humans if there were errors in the supply chain…

…and yes, it has fast-track status!

The not so good news is that FDA charges $58.00/ hour for staff time in dealing with a FOIA request. Since the Establishment Inspection Report (FEI) had already been requested, it only cost me 15 minutes, or $14.50. Others could cost more, a lot more.

For that reason, posts on FOIA request findings will be for paid subscribers only. I may even have to look at fund raising if there is something of great importance to get out.

So, this is the beginning of your introduction to the Pfizer/BioNTech real-world supply chain:

This is the link to the EIR, 86 pages in total

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