A pharmaceutical manufacturing site in Indiana, now owned by Novo Nordisk after their purchase of Catalent in 2024, has been reprimanded by the US Food and Drug Administration (FDA) for serious compliance issues. The FDA has classified the site as ‘official action indicated’, which is their most serious category. This means Novo Nordisk must take regulatory or administrative action to address the problems. The site, known as the Catalent Indiana fill-finish facility, received an FDA Form 483 confirming this classification last week. One of the site’s clients, Scholar Rock, confirmed this news. Scholar Rock’s application for their spinal muscular atrophy drug, apitegromab, was recently rejected by the FDA due to issues found during a routine inspection of the Catalent Indiana site. Scholar Rock emphasized that the issues were not specific to their drug and they are working closely with Novo Nordisk to address the situation. They plan to share more information during their third quarter update in November. Another client of Novo’s Catalent Indiana site is Regeneron. Their application to expand the use of their drug Eylea has also been delayed due to the issues at the site. Novo Nordisk acquired the site as part of their $16.5 billion deal to buy Catalent. An FDA inspection over the summer revealed numerous problems, including equipment issues and even the presence of cat hair. The full FDA report was later released by Stat News.