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FDA Identified Problems at Moderna Plant Making Substance for COVID Vaccine

U.S. Food and Drug Administration (FDA) inspectors uncovered problems at a Moderna plant used to manufacture a substance that is part of the company’s COVID-19 vaccine, according to a newly released document.

Moderna failed to meet multiple requirements, including rules aimed at minimizing the potential for contamination, according to the document.

FDA inspectors performed inspections at the plant in Norwood, Massachusetts from, Sept. 11 to Sept. 21, visiting nine times in total.

They found that equipment used to manufacture the substance was not cleaned properly before usage, that a mock cleaning done for manufacturing did not adequately simulate the actual process, that written alarm procedures were not followed, and that neither the equipment nor the plant were not designed in a way that would make contamination less likely.

Inspectors also learned that Moderna used materials beyond their expiration date.

“There are more than two thousand expired items stored in your … warehouse and cold storage at time of inspection,” Unnee Ranjan, the FDA’s lead investigator, wrote in a summary of the inspections.

The Epoch Times obtained the 6-page document, an FDA Form 483, through a Freedom of Information Act request after the FDA’s media office refused to release it.

The FDA under federal law has the power to inspect facilities and deliver a report setting forth any item produced in a facility that seems to “consist in whole or in part of any filthy, putrid, or decomposed substance” or “has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”

A Form 483 is a type of agency report containing “observations” that FDA inspectors “deem to be objectionable.” The observations are delivered to help companies comply with federal law and FDA regulations.

The substance in question was used in Moderna’s COVID-19 vaccine, mRNA-1273, the company’s sole product available to the public, according to the form.

Moderna released eight batches of the substance as it violated manufacturing rules, FDA inspectors said.

It was not clear whether any of the vaccines distributed commercially contained the substance in question.

“The FDA does not discuss compliance matters, except with the company involved,” an FDA spokesperson told The Epoch Times in an email.

“Upon receipt of the FDA’s findings, Moderna immediately and comprehensively updated the specific procedures identified and is confident that the actions taken will be satisfactory to regulators,” Moderna said in a statement.

Moderna said all product released by the company was tested and meets product specifications and international regulatory requirements.

Steven Lynn, a former head of the FDA’s Office of Manufacturing and Product Quality who is now a regulatory compliance consultant, said using the drug substance in question was a serious matter but that it was unclear whether the batches were released to consumers.

The FDA has not issued a recall of any Moderna vaccines, according to its recalls, market withdrawals, and safety alerts database.

In 2021, Japan suspended the use of 1.63 million doses of Moderna’s COVID vaccine after contaminates were found in some vials produced by Rovi, a contract manufacturer based in Spain. No manufacturing problems have previously been reported in any of Moderna’s own facilities.

Another part of the FDA report, dated Sept. 21, described how the Norwood facility did not have adequately designed air handling systems to “assure appropriate air quality in the … cleanroom in which the mRNA drug substance is manufactured.”

Inspectors also said they found positive air pressure was not “consistently maintained” between cleanrooms and airlocks and that monitoring data showed the cleanroom pressure turned negative between January and September. That development was “not assessed for potential impact,” they said.

“At face value, it appears multiple controls designed to prevent contamination were deficient,” Mr. Lynn said.

Another recently released document, produced by the nonprofit Informed Consent Action Network on orders from a federal judge, showed the FDA detected in Andover, Massachusetts, issues with the manufacture of a substance used in the Pfizer-BioNTech vaccine. Pfizer said in response it had taken actions to correct the issues.

  • Tamirose170 says:

    How strange – if a Baby Formula plant had even 1/2 of the Deficiencies that Moderna had on it’s 9 inspections = THAT plant would have been closed down. Matter of fact, the FDA did close down Baby Formula Plants without following up, notifying the proper authorities or making sure the proper quotas were increased at other plants to compensate for the plant they closed down.

    But since our Govt and many in or retired from Congress have their hands in the Financial Cookie Jar(s) for all 3 “Vaxx” jabs ~ they’ll just ignore all of those pesty sterile environmental deficiencies.
    Some have found scraps of metal shavings in the vials – equipment scraping together and the shavings falling into the sterile vials or intentionally put? .

    9 Inspections between Sept 11 and the 21st? It’s now been 4 months has anyone been back to check to see if ANY of the deficiency’s notes were fixed? Doubtful

    I will NEVER trust the FDA again. Trump needs to abolish quite a few agencies and start fresh with New Names/New Monikers w/NEW Leadership in each of them. All Executives or top level managers need Pink Slips. Start all over from scratch with all NEW agencies. FBI, FDA, CDC are the Top 3 to be destroyed. Trump should already be writing Policies and Procedure Manuals and hiring potential Directors for each of those Agencies and have 5000 employees ready to step into their new roles come Jan 2024. On the day of his Inauguration, the FBI offices all over the Nation need to be locked down, secured, IT geeks render the computers SAFE so no one from home can access them and “delete” the truth.

    A surprise BLITZ is the only way we’ll get every scrap of paper, every file, untampered computers – just pull the Fire Alarm, escort all of the Employees out then put new locks on every single building and release the “You’re Fired” email that gets sent to 25,000+ Then we know the Investigations CAN begin without anyone interfering or destroying the evidence.

    There has got to be a mind-boggling or mind-blowing reason as to why the FDA didn’t want to release their records for 75 years ~

    3 Class Action Lawsuits should be filed on all Three Vax Manufacturers because they intentionally harmed Americans and lied about safety & efficacy. Sue them for every nickel and claw back every dollar of profit that was made by “investors” . Fauci should not have a dime in any of his bank accounts and his mansions and vacation homes sold and proceeds liquidated to pay medical expenses of the Multi-Millions he harmed.

    IF our Govt can SUE all of the Tobacco Corporations and receive Billions from them because of the health issues smoking “CAN” cause; then using that SAME logic and legal battle why can’t John & Jane Q. Public sue the FDA, CDC and the 3 Pharmaceutical Companies for enticing consumers to use their product but that same product MAY or may not cause life-altering side effects, permanent cardiovascular damage, 100+ severe side effects, Bell’s Palsy and/or DEATH. They advertised on TV, Radio, Newspaper no different than how tobacco companies did. I think the FDA and the 3 Pharm. Companies are more dangerous to our health than any cigarette will be – Cigarettes can take decades, if at all, before health damages are seen whereas the Jab caused IMMEDIATE reactions, death or a 2-week delay before they collapsed. The VAXX is the deadliest FDA approved product in the World

  • John sweet says:

    And this is just the “One” caught out of how many? Over how long? Shoddy habits in manufacturing tend to be widespread cost cutting procedures, and inspection schedules are already known ahead of time, and the Moderna team certainly messed up not catching the error themselves!



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