FDA Uncovers QC Lapses at Moderna's Main Facility

According to a recent Reuters article, the FDA discovered quality control deficiencies at Moderna's primary manufacturing facility in Norwood, Massachusetts, during a routine inspection back in September. The FDA report outlined five observations, including concerns about equipment used in producing the drug substance for Moderna's COVID-19 vaccine, Spikevax, and an experimental mRNA cancer vaccine developed in collaboration with Merck & Co. The report raised alarms about eight batches of the "drug substance" being released using equipment that had failed the company's cleaning verification tests.