The U.S. Food and Drug Administration (FDA) has informed Danish drugmaker Novo Nordisk that the agency’s April 2026 re-inspection of its fill-finish facility in Bloomington, Indiana has been classified as Official Action Indicated (OAI).

According to the FDA, an OAI classification indicates a facility is “in an unacceptable state of compliance.” Based on a re-inspection in April, the agency previously cited Novo Nordisk’s fill-finish facility with eight observations — including persistent contamination and quality systems deficiencies — and hit the troubled Indiana site with a Form 483.

“We view this as part of an ongoing process and remain focused on the work already underway to address the agency’s observations, as the quality of the medicines we make remains a top priority,” a Novo Nordisk spokesperson said in an emailed statement to Pharma Manufacturing.  

The spokesperson said Novo Nordisk has invested “significant resources in improving operations and enhancing quality systems at the facility” over the past year, and that the Bloomington site remains an important part of Novo Nordisk’s operations.

“We will continue working collaboratively and transparently with the FDA as we move forward,” the statement read.

In June, a 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.

Recurring problems, customer impact

Last year, the FDA also classified Novo Nordisk’s Bloomington site with OAI status. 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 Novo Nordisk’s customers currently being impacted by the agency’s enforcement action is biopharmaceutical company Scholar Rock. On Friday, Scholar Rock issued a statement that Novo Nordisk on August 7 informed the company the FDA has determined that the re-inspection classification is OAI.

As a result, Scholar Rock said it will remove Novo Nordisk’s Bloomington fill-finish facility from its apitegromab Biologics License Application (BLA) with the agency for the treatment of patients with spinal muscular atrophy — and instead rely on a third-party provider.

Scholar Rock’s apitegromab BLA submission in March 2026 included two fill-finish facilities — the Novo Nordisk site in Bloomington and a second facility — providing “two independent paths to a potential FDA approval,” according to the company.

“We continue to be very pleased with our second fill-finish facility,” Scholar Rock CEO David Hallal said in a statement. “The data package that we agreed upon with the FDA at our Type C meeting has been submitted, the FDA review of the facility is advancing, robust supply for commercialization is ready and awaiting packaging and labeling at a third-party site, and importantly, the facility has demonstrated a strong track record of compliance, including recent successful FDA and EMA inspections.”  

Asked about the FDA’s Form 483 issued in April for Novo Nordisk’s Bloomington site, Scholar Rock reportedly told Jefferies analysts at the time that the company was “disappointed at the number of observations cited in recent Form 483” with “some appearing to resemble persistent/repeat issues.”