The information and concerns you shared in your messages were forwarded to the appropriate staff within FDA’s Center for Biologics Evaluation and Research (CBER).
Your email is very much appreciated. Thank you for taking the time to respond.
If I may also add, for whoever it may concern, that the issues I have raised in the document FDA has, indicate serious, life threatening non-compliances with cGMP and USP <1079> at the following facilities in the COMRINATY registered supply chain:
• Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, 1 Burtt road, Andover, MA 01810 (COMRINATY, BLA 125742, drug substance (DS) manufacture).
• Pfizer Manufacturing, Rijksweg 12, Puurs 2870, Belgium NV. (COMRINATY, BLA 125742, drug product (DP) manufacture.
If I receive no response to my comments, and it subsequently transpires that my concerns were valid, and patient safety was jeopardized by lack of FDA action, then I have done my level best to sound a warning bell calling for regulatory action.
That it may be JP Spatzier - but FDA is not in China, and it has to follow its own rules that have been in place since the Food, Drug and Cosmetics Act, 1938 and CFR Title 21.
I have just responded as follows:
Dear Matt,
Your email is very much appreciated. Thank you for taking the time to respond.
If I may also add, for whoever it may concern, that the issues I have raised in the document FDA has, indicate serious, life threatening non-compliances with cGMP and USP <1079> at the following facilities in the COMRINATY registered supply chain:
• Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, 1 Burtt road, Andover, MA 01810 (COMRINATY, BLA 125742, drug substance (DS) manufacture).
• Pfizer Manufacturing, Rijksweg 12, Puurs 2870, Belgium NV. (COMRINATY, BLA 125742, drug product (DP) manufacture.
• Rentschler Biopharma, Erwin-Rentschler-Str.21, 88471, Laupheim, Germany (COMRINATY, BLA 125742, (drug substance (DS) manufacture).
If I receive no response to my comments, and it subsequently transpires that my concerns were valid, and patient safety was jeopardized by lack of FDA action, then I have done my level best to sound a warning bell calling for regulatory action.
Sincerely,
Hedley
"The resources required to answer your questions are not available due to budget and time and staffing constraints."
They didn’t like the question Katherine 😂
CCP style nonsense
That it may be JP Spatzier - but FDA is not in China, and it has to follow its own rules that have been in place since the Food, Drug and Cosmetics Act, 1938 and CFR Title 21.