FDA 483 - Catalent Maryland Inc - November 17, 2021

Catalent Maryland, Inc. in Harmans, MD, a manufacturer of gene therapy and vaccine drug substance, was cited for significant deficiencies during an FDA inspection. Observations included manufacturing outside validated ranges, inadequate contamination controls for new products, insufficient quality oversight for investigations and inventory, deficient sample analysis procedures, and inadequate environmental monitoring. The firm also had incomplete investigations and insufficient storage space.