FDA findings at Moderna Covid-19 vaccine facility, highlight issues like improperly cleaned equipment, the use of expired materials, and insufficient measures to minimize contamination risks

An access to information request reveals an FDA inspection of Moderna's Covid-19 vaccine facility showed "improperly cleaned equipment, the use of expired materials during manufacturing, and a lack of design in both the equipment and facility to minimize the potential for contamination."

Documents obtained through an access to information request reveal some alarming findings after a Food and Drug Administration (FDA) inspection at Moderna's Covid-19 vaccine manufacturing facility in Norwood, Massachusetts, conducted between September 11th and 21st, 2023.

According to the FDA report, under observation one, it states, "Equipment used for drug substance manufacturing is not cleaned properly prior to its usage." It further notes, "Specifically, your firm does not ensure that the equipment used for drug substance manufacturing is appropriately cleaned before the manufacturing of mRNA-1273 drug substance."

Observation three states, "Separate or defined areas to prevent mix-ups are deficient," and explains that "Expired materials were found utilized beyond their expiration date, and restricted materials were utilized in mRNA drug substance production."

Observation five found that Moderna's "Equipment and facilities are not designed to minimize the potential for contamination," and highlighted that "Specifically, the air handling systems were not adequately designed and controlled to ensure appropriate air quality in the Grade C cleanroom in which mRNA drug substances are manufactured."

You can review the documents at the link below.

https://drive.google.com/file/d/1kzzTlW9GH9ff90YwdbD0nhZzenC0WgzJ/view?usp=sharing