FDA issues two Form 483s to Catalent’s Maryland gene‑therapy sites

The FDA issued two Form 483 observations to Catalent’s Maryland facilities that manufacture gene‑therapy products prior to a round of mass layoffs at the sites. The notices relate to manufacturing quality issues at sites that produce therapies for clients including Sarepta. The regulatory action increases scrutiny on CDMOs supplying gene‑therapy materials and underscores the operational and compliance risks that can disrupt clinical supply and commercialization timelines.