FDA freedom of information request on inspections carried out on Pfizer's Wyeth Biopharma
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Why a FOI request to the FDA?
Wyeth BioPharma is the manufacturer of the Pfizer/BioNTech covid injections, code named BNT162b2. It is a US-based company and its inspection record is available on the FDA website. This is the subject of the FOI, with the link to the FDAs reply:
Inspection at FEI Number 1222181, Wyeth BioPharma Division of Wyeth Pharmaceuticals
You can click on the link to read the letter, or this is the main body of the text:
“Dear Requester:
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
This FOI relates to the following Inspection at FEI Number 1222181, Wyeth BioPharma Division of Wyeth Pharmaceuticals:
Inspection End Date: 09/19/2023 Inspection ID: 1218069 Product Type: Biologics Classification: VAI. (Voluntary Action Initiated).
I wish to know what the voluntary action comprised and would like sight of the inspection report, if that were possible. Was there a further FDA inspection (biologics) to confirm that remediation activities in the VAI had been carried out satisfactorily?
In relation to the inspection below: Inspection End Date: 04/28/2017 Inspection ID: 1020234 Product Type: Biologics Classification: VAI.
I wish to know what the voluntary action comprised and would like sight of the inspection report, if that were possible. Was there a further FDA inspection (biologics) to confirm that remediation activities in the VAI had been carried out satisfactorily?
I would also like to know if there was a pre-approval inspection carried out at the Wyeth facility prior to the EUA for the Pfizer/BioNTech drug substance in the SARS-Cov-2 sterile injectables? If so, I wish to have sight of the inspection report.”
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