Issues at Catalent's Bloomington plant affected Moderna booster release

According to The Post's Sept. 20 article, the Food and Drug Administration inspection focused on production issues at the plant that bottles and packages the vaccine.

A copy of the redacted inspection report states that procedures "to prevent microbiological contamination of drug products purporting to be sterile" were not written or followed. The report was not a final FDA determination regarding compliance, but contained recorded observations made Aug. 27-Sept. 2.

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Between Aug. 11, 2021, and April 7, 2022, some batches were released "after exceeding the supplemental visible particles testing," an FDA observer wrote.

In response, Catelent provided an FDA statement that said because the inspection at the Bloomington plant was "still ongoing when FDA authorized the updated Moderna booster, FDA did not include this facility as an authorized manufacturing facility for the updated COVID-19 vaccine booster at that time. The agency has no concerns with the safety, effectiveness or quality of these batches."