The FDA has raised significant concerns regarding the manufacturing processes for Elevidys at Catalent’s Maryland facility, as detailed in a recent Form 483. This inspection report highlights critical shortfalls in compliance that could impact the quality and reliability of the gene therapy product. The timing of these findings is particularly noteworthy, coinciding with Catalent’s recent layoffs at its gene therapy manufacturing division, which raises questions about the operational stability and future of the site.
These concerns from the FDA not only underscore the regulatory challenges facing Catalent but also reflect broader issues within the gene therapy manufacturing sector. As companies navigate the complex landscape of regulatory compliance, the implications of such findings could lead to increased scrutiny from regulators and potential disruptions in supply chains. Stakeholders in the pharmaceutical industry must closely monitor these developments, as they may affect sourcing strategies and portfolio management in the gene therapy arena.
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