Petition for administrative action regarding COVID-19 modRNA products - FDA-2025-P-0335
But this article is more about what I found attached in the comments
A bunch of us have been working hard in the background to try to make some sense of the world, and maybe even get some justice for the many millions (perhaps billions) of people still suffering from the harms inflicted on them in the COVID-19 era. To be brief, Katie Ashby-Koppens of PJ O’Brien & Associates has successfully electronically-filed a citizen petition to the FDA system requesting that COVID-19 modRNA-LNP product authorization be revoked. The petition is assigned to docket number FDA-2025-P-0335.
Here’s the confirmation letter.
And here’s the petition.
Lo and behold, I was looking at the comments section where the petition rests and I noticed that someone named Daniel Saxelby MS MBA, had written a comment that included a couple of attachments (posted by the FDA on Jan 31, 2025).
One of them, a public document entitled catalentindianallc508ed, is quite illuminating, shall we say. Please do read the whole thing. It’s only 9 pages and it is redacted. It describes an FDA inspection performed at the end of 2023 of a “vaccine” product manufacturing company called Catalent Indiana, LLC who incidentally, did team up with Moderna and J&J. Catalent’s major customers include Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Haleon, Novo Nordisk, Moderna, Pfizer, and Sarepta Therapeutics. This is no start-up company.
Here’s a summary of the document by the FDA inspector’s OBSERVATIONS that describes the conclusions of the FDA inspection.
OBSERVATION 1
The responsibilities and procedures applicable to the quality control unit are not fully followed.
OBSERVATION 2
We observed numerous instances in which the Quality Unit did not appropriately exercise its responsibility to ensure that drug products manufactured meet applicable good manufacturing practices and meet established specifications of identity, strength, quality, and purity as is required by A-PO L-03- 01-001, Quality Manual.
OBSERVATION 3
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
OBSERVATION 4
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in process material and the drug product.
Variability, eh?
The screenshot below from page 2 of the document gives a good impression of the horror show.
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed.
No commercial lots of drug and biological drug products have been rejected due to ——- failures.
I wonder if that redacted part could read “your total f-ing”? That was a joke. What else can I do at this point?
I don’t see any indication here that these guys were doing much more than fill-finish manufacturing, but considering the fact that fill-finish involves important stuff like sterilization, filling, capping, labeling, and packaging, ensuring that the product remains sterile throughout the process, it seems like an important step not to get wrong. And these guys seemed to. Not ok. What are the physiological effects of likely contaminated vials? Did anyone bother to ask? Or look?
Even though these specific problems with this specific biologics bottling company might not have anything to do with DNA contamination (because the Moderna product solution was already prepared and formulated before they arrived at Catalent's facility, for example), they’re still a huge problem and raise serious GMP issues.
Considering the fact that out-sourcing, and lack of transparency are also huge and ongoing problems in terms of product reliability, we really have no idea who did what or where the various problem origins lie, and that’s kind of a crazy statement to make.
Many years ago in the 1980s, homes in my neighborhood built in the late 1970s began "settling" to a point where the concrete slabs broke, parts of floor of certain houses had sunk several inches while other parts hadn't, and many homes required extensive rehabilitation or entirely rebuilding. Several were unliveable for months, if not years.
Homeowners and home insurers sued the (very large) builder, and the builder argued in court they were not responsible while the builder sued the (not very large) subcontractor who graded the properties before concrete was laid. The builder won; they were not found liable, it was the sub's fault. Years after I found out I was friends w the daughter of the lawyer who argued it was the sub's fault; i learned that the ruling on this case was now precedent for many other liability cases--and the reason that builders hired subcontractors: to shield themselves from any liability.
The subcontractor was legally responsible but went immediately out of business and never paid anyone. the builder kept right on building without.Homeowners lost.
Using subcontractors is an intentional process to avoid accountability.
I was one of those who was certain in early 2020 that mRNA would be dangerous and dreaded that my children and grandchildren would be harmed. All of my warnings were derided. I remain, like so many, fearful of the long term effects that may present.