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Nicholas Saraceno is Editor of Pharmaceutical Commerce. He can be reached at nsaraceno@mjhlifesciences.com.
The fallout is impacting partners Scholar Rock and Regeneron, both of whom have pending regulatory applications tied to the facility.
Novo Nordisk’s recently purchased facility in Bloomington, IN—formerly owned by Catalent—is in a bit of hot water.
As first reported by Fierce Pharma,1 the plant had received an official action indicated (OAI) label from the FDA on Oct. 9, after inspecting the site this past July. According to the federal agency, this OAI designation means that a facility is in “an unacceptable state of compliance.” It was issued a Form 483 outlining the violations and ways to make the necessary changes as a result.
The industry may recall that the aforementioned plant reportedly had unaddressed cases of contamination by “atypical extrinsic particles,” including cat and human hair that were found in vial stoppers, and reports of pest infestations found in classified areas.2
“Your investigation failed to determine a root cause for the contamination, assess the potential impact to the rest of the lot, or evaluate whether similar issues may have occurred in upstream batches,” the official report obtained by STAT wrote.2 “The review of related deviations was limited to a one-year time frame, and no complaints were assessed. Although components were considered a potential root cause, no corrective or preventative actions were taken to address this. Since this time, approximately 20 additional deviations related to hair contamination during 100% manual visual inspection have occurred. In addition, approximately 14 other deviations were opened as a result of a gap analysis conducted in response to this deviation.”
As far back as June 2022, multiple clients had raised complaints about “foreign matter” or “particles” found in lots that were produced at the site. Fast forwarding to the February 2024 and May 2025 timeframe, the plant logged around 10 work orders for “recurrent leaks and other failures” in a specific system. Some of those faced significant repair delays.
This manufacturing plant also houses Scholar Rock, a biotech company that is currently trying to get its spinal muscular atrophy treatment (apitegromab) approved by the FDA. The agency reportedly rejected the company’s application for apitegromab with a complete response letter (CRL), citing issues with inspection of the Bloomington facility, although said problems were not directly to production of that particular drug.1
“We continue to work closely with Novo Nordisk, and we have requested a Type A meeting with FDA to discuss next steps for resubmitting our BLA,” Scholar Rock told Fierce Pharma.1
Regeneron is also housed in the facility, and is seeking two regulatory approvals3 of its own:
However, for patients who are concerned about accessing the drug, Regeneron reassured both patients and investors3 that “Eylea HD remains available in the US through vial administration for patients with wet agerelated macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). In the European Union, the Eylea 8 mg prefilled syringe is approved for use in patients with wAMD and DME.”
Another plan in the works for Eylea HD is a new manufacturing plant, an application for which Regeneron hopes to have approval for within the next three months.
References
1. Dunleavy K. Novo Plant Hit With FDA's Most Serious Inspection Classification, Portending Possible Delays for Partners. Fierce Pharma. October 13, 2025. Accessed October 14, 2025. https://www.fiercepharma.com/manufacturing/fda-slaps-novo-nordisks-indiana-plant-oai-label-which-bad-news-regeneron-scholar-rock
2. Saraceno N. Novo Nordisk’s Indiana Plant Flagged by FDA for Contamination and Safety Lapses. Pharmaceutical Commerce. August 25, 2025. Accessed October 14, 2025. https://www.pharmaceuticalcommerce.com/view/novo-nordisk-indiana-plant-fda-contamination-safety-lapses
3. Regeneron Provides Update on Eylea HD (aflibercept) Injection 8 mg Regulatory Applications Under Review by the FDA. Regeneron. October 13, 2025. Accessed October 14, 2025. https://investor.regeneron.com/static-files/9a242a13-dae0-484c-a44b-4859e578df8d