12.18.23
Following an inspection conducted in September 2023, the U.S. FDA found quality control issues at Moderna’s primary manufacturing facility in Norwood, MA, where the company manufactures its COVID-19 vaccine, Spikevax, and an experimental mRNA cancer vaccine being developed with Merck, according to an exclusive report obtained by Reuters via a Freedom of Information Act request.
According to Reuters, the Form 483 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.
It is unknown if those batches were released to the public, according to the FDA report, but the the drug substance involved was identified by the FDA as being for the COVID vaccine. The agency declined to comment on the report, according to Reuters.
The FDA also cited in its report that Moderna did not have the right measures at its facility to ensure expired materials were not used to make vaccines and that airborne contaminates did not make it into any products, according to Reuters.
The Form 483 cited more than 2,000 expired items in Moderna's warehouse and cold storage not held in a separate or defined location from other materials, and the FDA found materials were used beyond their expiration date, according to the report obtained by Reuters.
According to its recalls, market withdrawals, and safety alerts database, the FDA has not issued a recall of any Moderna vaccines.
According to Reuters, the Form 483 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.
It is unknown if those batches were released to the public, according to the FDA report, but the the drug substance involved was identified by the FDA as being for the COVID vaccine. The agency declined to comment on the report, according to Reuters.
The FDA also cited in its report that Moderna did not have the right measures at its facility to ensure expired materials were not used to make vaccines and that airborne contaminates did not make it into any products, according to Reuters.
The Form 483 cited more than 2,000 expired items in Moderna's warehouse and cold storage not held in a separate or defined location from other materials, and the FDA found materials were used beyond their expiration date, according to the report obtained by Reuters.
According to its recalls, market withdrawals, and safety alerts database, the FDA has not issued a recall of any Moderna vaccines.
