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 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.
Reuters contributed to this report.
