FDA EIR - Catalent Maryland Inc - November 17, 2021

An FDA inspection of Catalent Maryland Inc. was conducted from November 8-17, 2021, under the regulatory framework of CP 7345.848 for Biological Drug Products (CBER), focusing on Somatic Cell and Gene Therapy manufacturing as a full Good Manufacturing Practice (GMP) inspection. The inspection was specifically prompted by a significant cross-contamination event involving a licensed gene therapy product with another gene therapy manufactured at the facility. At the conclusion, a seven-item Form FDA 483 was issued, highlighting several critical deficiencies. Main issues included the manufacturing of a product outside validated ranges, inadequate procedures for introducing new products to prevent facility or product contamination, and insufficient quality oversight for investigating errors. Further observations noted deficient procedures for sample analysis, shortcomings in the environmental monitoring system within classified processing areas, incomplete investigations, and inadequate storage space for materials and laboratory samples. Management confirmed their intention to provide a written response to the FDA 483, outlining their required corrective actions to address these serious compliance concerns.