Catalent’s Covid-19 vaccine manufacturing site hit with Form 483 over foreign objects in vials and other QC issues
An Indiana-based Catalent facility that produces Covid-19 vaccines is facing scrutiny from the FDA over an inspection last month.
Catalent’s plant in Bloomington, IN, which handles fill and finish operations as well as commercial scale biomanufacturing, was hit with a 19-page Form 483 from the FDA. The inspection reported a total of 12 major observations made when the facility was inspected between Aug. 1 and Sept. 1.
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