FDA Flags Novo Nordisk’s Indiana Plant as Highest Risk

FDA has classified its April 2026 re-inspection of Novo Nordisk's fill-finish plant in Bloomington, Indiana as Official Action Indicated — the agency's most serious compliance rating, signaling violations serious enough to warrant follow-up enforcement. The site, a former Catalent facility Novo Nordisk acquired in its 2024 acquisition of the contract manufacturer, has now delivered its second consecutive troubled inspection outcome, and at least one sponsor has already rewritten a pending FDA filing to route around it.

A site with a troubled recent history

Novo Holdings completed its $16.5 billion acquisition of Catalent in December 2024. As part of the same transaction, Novo Nordisk separately paid roughly $11 billion to acquire three of Catalent's sterile fill-finish sites outright — in Bloomington, Indiana; Brussels, Belgium; and Anagni, Italy — adding fill-finish capacity for its GLP-1 franchise, Ozempic and Wegovy among them. The Bloomington plant came with a compliance history already under strain: trade press has reported an FDA warning letter at the site tied to an earlier inspection, and this April's re-inspection is the follow-up FDA conducted to check whether the underlying problems had actually been fixed.

What the re-inspection found

Trade reporting on the resulting Form 483 describes eight observations. The recurring theme is contamination that prior corrective actions did not resolve: particulate matter, including mammalian hair, found in or around the stopper region of fill-finish vials, and aseptic-processing and water-leakage events that FDA investigators found had continued despite the site's own root-cause investigations. An Official Action Indicated classification is FDA's judgment that those findings, taken together, leave the facility in an unacceptable state of compliance — the rating that typically precedes a warning letter or other formal enforcement action, distinct from the milder "Voluntary Action Indicated" outcome FDA uses when it expects a firm to fix problems on its own.

The filings caught in the middle

An OAI classification at a contract fill-finish site does not stay contained to the site owner; it follows every sponsor whose product lists that facility in an open FDA application. Scholar Rock said it was notified of the classification by Catalent Indiana LLC on 7 August 2026 and, because its Biologics License Application for apitegromab — a spinal muscular atrophy candidate — had listed two independent fill-finish facilities, removed the Indiana site and left FDA's review to proceed on the second, previously listed plant alone. The company has said its 30 September 2026 PDUFA action date remains on track. Trade press has also reported that Regeneron holds pending applications, including for the eye-disease treatment Eylea, that are tied to manufacturing at the same Indiana facility, and that the classification complicates the path forward for that review as well.

The broader CMC lesson

Scholar Rock's pivot worked only because its filing already named a second, independent fill-finish site — the kind of built-in redundancy FDA's own device user-fee performance-goal negotiations have separately been pushing sponsors toward as review timelines compress. Sponsors whose BLAs or NDAs list only the Bloomington plant, or whose supply chains route through it as a sole source, do not have that option; for them, an OAI classification means a paused or redirected review until the facility either clears a follow-up inspection or the sponsor requalifies an alternate site. FDA has not published a timeline for Novo Nordisk to resolve the classification, and the agency's own device and drug user-fee goals do not toll while a facility's compliance status is worked out.