FDA 483 - Catalent Massachusetts, LLC - November 30, 2021

An FDA inspection of Catalent Massachusetts, LLC, a drug product manufacturer in Chelsea, MA, revealed significant deficiencies across four observations. The firm was cited for inadequate equipment requalification, insufficient procedures to prevent objectionable microorganisms, and failure to validate supplier analyses for components. Additionally, cleaning and maintenance procedures for GMP manufacturing areas were found to be deficient.