US FDA finds control lapses at Moderna manufacturing plant

U.S. drug regulators in September found quality control lapses at Moderna’s main factory including with equipment used to manufacture drug substance for its COVID-19 vaccine, according to the report obtained by Reuters via a Freedom of Information Act request.

The Sept. 11-21 inspection by the U.S. Food and Drug Administration took place at Moderna’s facility in Norwood, Massachusetts, which is used to manufacture the company’s COVID shot Spikevax and an experimental mRNA cancer vaccine being developed with Merck & Co.

The FDA report noted five separate observations, including that Moderna had released eight batches of "drug substance" - the active ingredient used to make mRNA vaccines - that was produced with equipment that had failed the company's cleaning verification tests.

The FDA did not say in the report if those batches were released to the public but identified the drug substance involved as being for the COVID vaccine. The agency declined to comment on the report.