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FDA Finds Flaws at Catalent Vaccine Facility

The company received 179 complaints about the presence of particles in their pharmaceuticals.

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A recent Bloomberg article discussed issues identified at a vaccine manufacturing facility that prompted a deeper investigation. The factory in question is Catalent Inc., which produces Moderna’s COVID-19 vaccine. Back in June of 2020, Moderna approached Catalent to fill and package its vaccine. Ten months later, the companies announced Catalent would designate a new high-speed filling line to Moderna’s vaccines and other potential products through June 2023.

Over two years ago, the company received 179 complaints regarding visible particles in their products. An FDA inspection of their Bloomington, Indiana facility found that the company’s protocols to prevent contamination were not adequate. Moderna asked the FDA to review certain batches of the vaccines produced at the plant, and release them to meet the high demand of the fall booster push. Catalent says it is addressing the concerns of the agency, and that production at the facility has continued without interruption.

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