FDA 483 - Catalent Maryland, Inc. - April 09, 2025

An FDA inspection of Catalent Maryland, Inc. in Baltimore, MD, a biological drug product manufacturer, revealed two significant observations. The firm failed to follow procedures designed to prevent microbiological contamination during sterile filling operations and did not maintain its manufacturing buildings in a good state of repair, specifically noting floor damage in a critical area. These issues indicate potential risks to the sterility and quality of drug products.