A recent regulatory action by the U.S. Food and Drug Administration (FDA) has brought a manufacturing plant in Bloomington, Indiana, into focus. On December 2, 2025, the agency issued an official warning letter to the facility, which was formerly operated by contract development and manufacturing organization (CDMO) Catalent. This development underscores the persistent regulatory oversight facing pharmaceutical production sites, even after changes in corporate ownership.
The warning stems from an inspection that concluded with a Form FDA 483 report in July 2025 and a subsequent classification of “official action indicated.” The site in question was one of three fill-finish operations acquired by Novo Nordisk as part of a broader transaction. Novo Holdings completed its acquisition of Catalent for approximately $16.5 billion in December 2024. Catalent’s shares were subsequently delisted, with the final public trading occurring in February 2025.
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Partner Responses and Supply Chain Implications
The FDA’s move has prompted reactions from companies that previously relied on the site. Scholar Rock Holding Corporation addressed the situation on December 2, stating that, based on current information, it still plans to resubmit its biologics license application for the spinal muscular atrophy treatment Apitegromab in 2026. However, the biotechnology firm has proactively secured alternative capacity for commercial fill-finish manufacturing as a precaution. The warning letter suggests potential ongoing quality control issues at the Indiana plant, which is now under the management of Novo Nordisk.
Strategic Focus for the Privatized Entity
For Catalent, now operating as a private company within Novo Holdings, the strategic path forward involves concentrating on key initiatives and continuing to provide manufacturing solutions globally. The firm, which unveiled a new corporate brand identity in October 2025, maintains a network of nearly 50 facilities worldwide. Resolving the FDA’s concerns regarding the Indiana plant will be a critical task for Novo Nordisk, as well as for any supply chains dependent on output from the former Catalent location. The operational performance and regulatory standing of the privatized Catalent remain vital to its role and value contribution within the healthcare sector.
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