Very Bad Manufacturing Practices

Nobody knows what's in the vials.

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Use of EUA covered countermeasures under Public Health Emergency cannot constitute a clinical investigation (21 USC 360bbb-3(k)).

Therefore, these countermeasures could not be tested for safety and efficacy in accordance with US law (CFR 21), nor could compliance with current Good Manufacturing Practices (cGMP) or Good Distribution Practices (cGxP in general) be enforced by the FDA. 

This legal fact was known to high-level FDA officials, to DOD and BARDA officials and to the pharmaceutical companies signing these contracts. 

This fact was not known to the American public, clinical investigators, clinical trial subjects, or most of the lower-level employees of the pharmaceutical companies and the US Government.

This video presentation addresses the evidence of VERY BAD Manufacturing Practices for Covid-19 countermeasures.

Evidence of noncompliance with cGMP for Covid-19 Countermeasures (aka “Vaccines”)

A substantial body of evidence exists demonstrating lack of current Good Manufacturing Practices (cGMP) compliance for Covid-19 vaccine countermeasures. 

A consumer or a healthcare provider usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work, and therefore safety testing and assurance processes are needed.

Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems; obtaining appropriate quality raw materials; establishing robust operating procedures; detecting and investigating product quality deviations; and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

While cGMPs require testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the cGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how cGMP requirements help to assure the safety and efficacy of drug products.

If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the law. The majority of product recalls are voluntary by the manufacturers; however, the FDA has power to enforce cGMP compliance and force recalls, product seizure and a variety of other regulatory actions to ensure compliance.  

Without cGMP compliance:

  • Neither the manufacturers nor the regulators can verify that the ingredients in vaccine doses as dispensed are present in the quantities specified.  It is possible that a large percentage of the US population received sham vaccinations, or doses that were lacking key ingredients, and it is equally possible that a very large number of people were injured by overdoses and/or dangerous process related contaminants in these shots.