FDA Identified Problems at Moderna Plant Making Substance for COVID Vaccine: Document

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.

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