Epoch Times By Zachary Stieber 12/31/2023
Moderna didn’t meet required rules, regulators found.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.
More:
https://www.theepochtimes.com/us/fda-identified-problems-at-moderna-plant-making-substance-for-covid-vaccine-document-5555884?utm_source=epochHG&utm_campaign=CFP&src_src=epochHG&src_cmp=CFP
