Novo Nordisk’s troubled Indiana site hit with Form 483 following FDA re-inspection

Despite previous corrective actions, a former Catalent site in Bloomington, Indiana — acquired in late 2024 by Novo Nordisk — continues to be plagued with regulatory problems. Following an April 2026 re-inspection, the FDA cited Novo Nordisk’s fill-finish facility with eight observations including persistent contamination and quality systems deficiencies, according to Jefferies analysts.

In a May 27 note to investors, the analysts described the observations in the FDA’s Form 483 as falling into three key themes: persistent contamination/control issues, inadequate contamination control and inspection validation, as well as quality systems and investigation deficiencies.

“FDA cited recurring particulate contamination findings (eg, mammalian hair) and repeated aseptic processing/water leakage events that continued despite prior corrective actions and root-cause investigations,” the analysts wrote.

A Novo Nordisk spokesperson in an emailed statement to Pharma Manufacturing said the company remains committed to bringing the Bloomington site into full compliance with its global quality and manufacturing standards, while adding that the Danish drugmaker is committed to addressing each of the FDA observations thoroughly and promptly.  

“We welcomed the FDA’s recent inspection of the facility as an expected and important step in our ongoing work at the site,” the spokesperson said. “We are confident this inspection was a step in the right direction and reflects the meaningful progress we have made. We are now focused on implementing the [Corrective and Preventive Actions] developed in response to the inspection observations while we await the FDA’s formal results in the coming months.”

The Novo Nordisk spokesperson called out one of the FDA’s re-inspection findings — the agency’s “mammalian hair” observations — noting that the contamination was detected as part of the company’s “normal manufacturing controls” and that “all affected batches were identified, documented, and will be rejected pending closure of the investigations.”

The spokesperson went on to emphasize that Novo Nordisk believes this distinction “between contamination found and caught during manufacturing versus contamination found in released product” is an important one.

According to Jefferies analysts, the FDA has 90 days from the end of the inspection — April 24, 2026 — to classify the Bloomington site. The agency “may use much or all of the full 90-day post-inspection review period before making a final decision on classification,” the analysts wrote in their May 27 note to investors.

Impacts on customers Regeneron, Scholar Rock

In 2025, the FDA classified Novo Nordisk’s Bloomington site with Official Action Indicated (OAI) status in which a facility is deemed to be “in an unacceptable state of compliance” following the issuance of a Form 483 at the conclusion of an inspection.

At the time, Novo Nordisk said it was “in active dialogue” with its contract development and manufacturing organization (CDMO) customers about the matter. One of those contract manufacturer customers is Regeneron, which last year received a Complete Response Letter (CRL) from the FDA for its blood cancer therapy odronextamab application.

Novo Nordisk’s Bloomington site handles the final stages of drug preparation and packaging for odronextamab as well as Regeneron’s eye disease drug Eylea HD.

Regeneron resubmitted its application seeking FDA approval for filling of the EYLEA HD pre-filled syringe (PFS) at Novo Nordisk’s Bloomington site, where the agency’s re-inspection was conducted in April 2026. That same month, the FDA did not act by the PDUFA date for Regeneron’s regulatory application for a second contract manufacturer for the PFS.

Jefferies analysts reached out to Regeneron regarding the FDA’s Form 483 issued to Novo Nordisk in April and what it means for applications. The company commented that they are “aware of the inspection report but had no additional color to provide on the observations or remediation process.”

Regeneron also said an alternative manufacturing site is continuing to work with the FDA to resolve issues identified during a pre-approval inspection conducted earlier this year and that the review is ongoing, according to the analysts.

“While the decision to inspect/reinspect is solely at the discretion of the FDA, there’s currently no indication an additional FDA re-inspection will be required prior to an FDA decision on this application,” the analysts wrote.

Regeneron said in late April that both Novo Nordisk and the other unnamed third-party filling manufacturer are “working closely with the FDA to resolve all outstanding issues, and the company anticipates a regulatory decision on one or both applications during the second quarter of 2026.”

In September 2025, Scholar Rock announced that the FDA issued a CRL for its apitegromab application for the treatment of patients with spinal muscular atrophy, following an FDA Form 483 issued to Novo Nordisk based on an inspection of the Bloomington site.

Asked about the FDA’s latest Form 483 issued in April, Scholar Rock — another one of Novo Nordisk’s CDMO customers — told Jefferies analysts the company was “disappointed at the number of observations cited in recent Form 483” with “some appearing to resemble persistent/repeat issues.”

However, according to the analysts, Scholar Rock doesn’t believe another FDA re-inspection of Novo Nordisk’s Bloomington site will be necessary, while the company has “high confidence” in a second fill-finish facility as the site already manufactures approximately three-dozen approved commercial products and has a strong regulatory inspection history.