In an inspection of Moderna manufacturing practicing in September 2023, the FDA found “serious quality control issues” at the company’s main production site, including issues with its COVID-19 Spikevax.

The FDA issued a Form 483 warning letter notifying Moderna that its quality practices were out of compliance, but that letter has yet to be released to the public. Instead, the FDA publicly called the inspection a “routine” one that “met product specifications and international regulatory requirements.” A Freedom of Information Act (FOIA) by Reuters, however, showed that “the FDA inspectors cited five distinct observations including the company’s failure to verify cleaning tests concerning production equipment used to make the COVID-19 vaccine.”

Aside from problems with the facility’s cold storage practices, the inspection turned up 2,000 expired items in the warehouse. “Another indicator of slipping quality were materials put to use beyond the appropriate expiration date,” according to TrialSite News. Yet, the FDA still chose not to make a public disclosure of the event — and it took an FOIA by Reuters to learn about it.

“Not known at this point is whether the batches under scrutiny made their way to the public. The agency declined to comment to Reuters,” TrialSite said. “Why did Reuters have to issue a FOIA? Why hasn’t the FDA shared the 483 letters with the public as typically done?”  

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TrialSite News December 17, 2023