FDA 483 - Catalent Maryland Inc - April 28, 2025

Catalent Maryland, Inc., a gene therapy manufacturer in Harmans, MD, was cited for multiple deficiencies during an FDA inspection. Observations included a lack of identity testing for incoming drug substance, inadequate sterility testing procedures, and unqualified manufacturing equipment. Further issues involved a deficient environmental monitoring program, inadequate personnel qualification for vial inspection, and failure to follow record retention procedures.