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After hearing about quality control lapses at a Moderna COVID-19 vaccine manufacturing facility, ICAN's legal team immediately sent FOIA requests to FDA for more details. ICAN has now obtained FDA's inspection report, which includes detailed descriptions about the conditions at the plant. In addition, ICAN submitted follow-up requests to dig even deeper.
Lead Counsel, Aaron Siri, Esq. details the shocking new information here:
On December 15, 2023, news broke that FDA found numerous quality control lapses during its September 11 to September 21, 2023 inspection of Moderna's Norwood, Massachusetts facility, where it manufacturers its COVID-19 vaccine.
ICAN's attorneys immediately submitted several FOIA requests to get more details on the inspection's findings. In response, FDA recently produced this report to ICAN which has some stunning findings, including air and temperature alarms that were ignored, use of expired materials in the mRNA vaccines, failure to collect cleaning verification samples, and failure to design and control air handling equipment to reduce potential for contamination.
Incredibly, the report notes that Moderna "does not ensure that the equipment used for drug substance manufacturing are appropriately cleaned prior to the manufacturing of mRNA-1273 drug substance" and then proceeds to list the drug substance batch numbers that were manufactured using equipment utilized "without confirming the cleaning verifications test results for bioburden and endotoxin prior to the usage for subsequent batch manufacturing."