Reminder: there are no requirements for FDA inspections of biologics facilities
Scott Gottlieb is a prototypical corrupt leach, shuttling between government and corporate feeders. He was the 23rd commissioner of the Food and Drug Administration (FDA) from May 2017 until April 2019. He is presently a senior fellow at the [obviously fake-] conservative think tank the American Enterprise Institute(AEI), a partner at the venture capital firm New Enterprise Associates (NEA), a member of the board of directors of drug maker Pfizer, Inc and gene sequencing company Illumina, Inc., and a contributor to the cable financial news network CNBC and the CBS News program Face the Nation. Yada, yada, you get the idea…
Among other things not mentioned on his Wikipedia page, he is affiliated with the CIA-backed biomanufacturing company - Resilience and he personally profits from deploying bio-chemical poisoning agents on people worldwide.
Here is a good review of Resilience (aka Nanotherapeutics, aka Ology and a few other names). Click on the link:
https://twitter.com/Cancelcloco/status/1735421884395860246
I would like to highlight this post by Katherine Watt explaining the rule change for manufacturing facilities inspections that was made by Scott Gottlieb while FDA Commissioner, before departing for greener pastures being the board member of bio-manufacturing facilities.
Until May 2, 2019, FDA inspectors were required to inspect all establishments or facilities producing biological products at least once every two years, and held eight enumerated inspection duties.
Since May 2, 2019, FDA inspectors have had none of those duties, and are not required to inspect biological product manufacturing facilities at any time intervals.
Prior to the rule change, 21 CFR 600.21, Time of inspection, read:
The inspection of an establishment for which a biologics license application is pending need not be made until the establishment is in operation and is manufacturing the complete product for which a biologics license is desired.
In case the license is denied following inspection for the original license, no reinspection need be made until assurance has been received that the faulty conditions which were the basis of the denial have been corrected. An inspection of each licensed establishment and its additional location(s) shall be made at least once every 2 years. Inspections may be made with or without notice, and shall be made during regular business hours unless otherwise directed.
Effective May 2, 2019, the last three sentences of 21 CFR 600.21 were removed.
There is currently no legal requirement for an initial FDA inspection; no minimum interval for subsequent FDA inspections, and there are no legal consequences for compliance failures, such as establishment or product license denial or revocation.
I would like to emphasize that this change was made by Scott Gottlieb, who holds financial interests in several large biologics manufacturers and genetic sequencing equipment companies.
This explains why the FDA has not audited Pfizer and Moderna prior to large scale commercial deployment of Poison-19 “vaccines”. At the time, in late 2020 to 2021 they claimed it was dangerous to send inspectors out due to covid. I find this lie curious: they could have just pointed to the rule change made by Gottlieb in 2019, but they didn’t. They needed the excuse of “covid” to misrepresent the true state of things to the public and to professionals. They needed the Potemkin village of “quality biopharmaceutical manufacturing”. Later in 2022 some of the inspections were done at suppliers - all found non cGMP compliant. Zero enforcement action resulted from these findings. Finally, in September 2023 Moderna was inspected and failed to demonstrate cGMP compliance. No enforcement actions have been brought by the FDA, and none are expected, since it is legal to ship adulterated and misbranded EUA Countermeasures.
I am tired of repeating this to several “experts” ostensibly on the health freedom side, who just can’t figure out this part. Just a few days ago, I was copied on this email by Hedley Rees, who calls himself a pharmaceutical expert with 40 years of experience, and is based in the UK. I have explained to Hedley many, many times why there is no FDA (or MHRA, or EMA, or TGA, or Health Canada) enforcement of pharmaceutical regulations such as Good Manufacturing Practices (cGMP) for covid vaxxes. It’s not difficult to understand, it’s a matter of both the EUA law and the non-regulation of biologics explained above. He consistently pretends to not understand, and has recently accused me and Katherine Watt of being “controlled opposition”. Yawn. How original… I am sick and tired of experts pretending not to know or understand things that regular people without conflicts of interest understand quite easily. As I learned early in my professional career, there is much more money in NOT solving a problem… Here is the email exchange. It was not private, it was sent to many people on the email distribution list:
Hedley’s email:
Dear Dr Califf,
This is an open letter in follow-up to a question I have submitted to the FDA’s Center for Biologics Evaluation and Research (CBER). The question is repeated below:
Dear FDA,
My question relates to FDAs release of the Moderna booster vaccine, reported in a Fierce Pharma article dated September 21, 2022, titled:
Moderna’s new booster launch tripped up by production issues at Catalent plant: reports
This is a short excerpt:
On Tuesday night, the FDA released (PDF) a Form 483 notice it had sent to Catalent, citing 12 observations from a lengthy August inspection of its Bloomington, Indiana, site. The massive facility is among the largest in the portfolio of contract manufacturing powerhouse Catalent. Most of the observations had to do with quality control, record keeping and the failure to establish and follow procedures. The FDA noted a failure to address unexplained discrepancies in a batch of drug product (DP).
The detailed findings of highly experienced inspectors, although redacted in parts, paint a picture of deep systemic failure at the Bloomington facility. Each of the 12 observations in the 18 page report demonstrate critical non-compliance with cGMP.
Even more surprisingly, the article reveals that the Bloomington facility had received a previous Form 483 during August 27, 28, 31, September I, 2, 2020, stating:
The first sign of trouble at the Bloomington plant came in September of 2020, when the FDA cited (PDF) the company for a lack of procedures to prevent contamination.
You will no doubt appreciate that contamination of biological products is an instant ‘red flag’, given that these vaccines are ‘sterile injectables’. Contamination renders the products non-sterile, presenting serious risk to patients. Surely, this was an important ‘early warning’ that was missed by the FDA?
At the very least, one would expect the FDA to exercise its powers, such as issuance of a consent decree, to provide greater reassurance that the Form 483 inspection report observations were remediated to FDAs satisfaction. You will remember that FDA deployed a consent decree when Johnson & Johnson’s McNeil failed to remediate quality issues from 2007 – 2011, as detailed by Warren Adis, Hagan School of Business, Iona College, below:
McNeil, a Johnson & Johnson Subsidiary: FDA Case Study.
Finally, my question above ended:
I wish to better understand the decision-making process within the FDA that authorized resumption of production at the Bloomington facility, given the extensive Form 483 issues identified, such as shipping products prior to quality release.
I look forward to your urgent response to my question.
Yours sincerely,
Hedley Rees
Is this a bad letter to the FDA? NO! It’s a great letter. The problem is this question has been asked and answered hundreds of times, and asking it yet again is, like… after all this… are you a virgin now?
My response to Hedley’s email (note, this is maybe 4th time I have given him this information, with detailed citations from the US and EU law):
Please post any response from Califf. I know him personally. At one point in mid- 2000's my colleagues and I stopped him from organizing an illegal price-fixing industry cartel. So, he is perfect for his current role as a fixer in a criminal military government cartel.
The answer to your question - according to current US law, EUA Countermeasures are not subject to any enforceable cGMP regulations. The FDA does not have the duty to act on the Form 483 finding. The EUA Countermeasures can be legally adulterated, misbranded, and everyone in the supply chain is allowed to lie about it. https://sashalatypova.substack.com/p/memo-re-eua-countermeasures-to-send?r=uaapz
If you get anything different from him, that would be interesting.
Best Regards,
Sasha
PS. me stating these legal and historical facts does not make me a member of the controlled opposition as you decided to call me in one of your posts.
Hedley received a template response to his inquiry. Not from Robert Califf of course, just a form letter from the FDA stating, basically, “we don’t give a shit about inspections” (I am paraphrasing).
Hedley says:
I have receive feedback from FDAs CBER's Manufacturers Assistance and Technical Training Branch (MATTB). It was a very honest and open response, as FDA used to be, with this being the core of it:
The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. The FDA Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.
So, top management at FDA decided to ignore an inspection that demonstrated significant lack of control and non-compliances in cGMP at the Catalent Bloomington facility manufacturing the Moderna booster jabs. This is the inspection report again:
https://www.fda.gov/media/170450/download?attachment
This is a later one at the same facility: https://www.fda.gov/media/170260/download?attachment
This is a later one again, same facility: https://www.fda.gov/media/177229/download
The question must be asked why FDA has not used its powers to issue a Consent Decree at the very least ((FDA takes over running the facility). This is clearly a dangerous facility wrt patient safety, and in my professional opinion should cease production immediately while remediation activities commence.
Regards,
Hedley
OK then! My pronouns are Told/You/So.
Consent decree is when FDA essentially takes over quality control of a manufacturer that is chronically unable to perform to the pharmaceutical regulations. Kind of like conservatorship. I did tell him there is no requirement/duty/snowball-chances-in-hell of the FDA issuing a consent decree, as they have never planned to enforce investigational pharmaceutical regulations onto non-investigational EUA Countermeasures.
The situation is worse, since the Gottlieb’s inspection rule change affects ALL biologics manufacturing, not just EUA Countermeasures. This includes all vaccines, human and animal, and all other biologics products. These products include medications for a variety of autoimmune conditions which patients typically take for life, monoclonal antibodies, and some cancer meds. Here is the list of top 10 selling biologics products (and biosimilars, which are generic biologics). Now all these medications can be shipped adulterated for years, and there is no regulatory mechanism of catching the problem other than random luck. In case of non-EUA products, the manufacturers face liability for harming consumers, however, identifying adulteration of these products requires complex lab set up and expertise, not something easily accessible to a harmed consumer. That’s why the FDA was originally established, which is proudly stated on the FDA website (emphasis added):
Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs.
Thanks to Gottlieb, there is no such prohibition anymore. In that case, why do we have the FDA? Rhetorical question, since there is no real regulation of vaccines and biologics, we have discovered that it’s always been a façade:
Art for today: George Eastman, commissioned portrait. George Eastman founded Eastman Kodak in Rochester NY, was an “Elon Musk” of the time, died by suicide because he “suddenly” acquired a terminal neurodegenerative condition and did not want to become a vegetable. IMO, it was a vaccine injury.
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