Despite boasting a new owner, the Indiana manufacturing plant Novo Nordisk picked up as part of its parent company's Catalent buyout last year continues to catch flak from the FDA.
Novo has received an FDA Form 483 at the Bloomington, Indiana, facility after an agency inspection of the site in late June and July, Stat first reported. The six-observation citation—which was obtained and published by Stat—details a range of manufacturing infractions, including the improper investigation of contaminants and equipment failures.
This isn’t the first time the Bloomington site has landed in the FDA’s crosshairs, and the latest write-up comes as the facility has been implicated in the delay of regulatory verdicts on Regeneron’s Eylea HD and the rejection of a separate Regeneron cancer med, both of which are manufactured at Novo’s plant.
In an emailed statement, a Novo Nordisk spokesperson confirmed receipt of the Form 483 and told Fierce Pharma that the company considers adherence to good manufacturing practice guidelines a “top priority.”
“We take all observations seriously and have initiated a thorough review of our processes and procedures,” the spokesperson said. “A comprehensive response will be implemented to address the Form 483 observations promptly and holistically.”
Novo welcomes further FDA inspections as it endeavors to “ensure continuous improvement and, ultimately, ongoing patient safety,” the spokesperson added.
The FDA’s first observation drilled into the handling of investigations at the plant, which were not always conducted correctly or followed through on, according to the 483.
In particular, Novo failed to properly follow up on the discovery of a piece of cat hair at the plant, as well as “an ongoing trend" of human hair ending up in vial stoppers, the FDA wrote in its report.
The company also neglected to fully assess the potential impact of a bacterial incursion at the plant, and it didn't identify root causes or corrective actions when “pests” were found in “classified areas," according to the document.
In addition, the FDA found Novo “failed to investigate all critical equipment failures that have the potential to impact drug products,” according to the write-up.
In the subsequent observations, the FDA critiqued the plant’s procedures to prevent microbiological contamination, flagged inadequate monitoring of environmental conditions in aseptic processing areas and questioned whether Novo’s control procedures were sufficient to maintain consistency of drugs produced at the plant.
The regulator’s final reprimand centered on Novo’s practice of accepting analyses from component suppliers without running its own tests. In particular, the FDA took issue with this practice as it pertained to supplier “shipments of high-risk components polysorbate 20 and polysorbate 80,” which are used to make multiple drugs, including Regeneron’s ophthalmology blockbuster Eylea and its cancer med Libtayo, according to the Form 483.
Novo acquired the Bloomington site along with two others from Catalent upon the close of Novo Holdings’ acquisition of the CDMO giant in December. Novo Holdings acts as a holding company for the drugmaker Novo Nordisk. Both companies operate under the banner of the Novo Nordisk Foundation.
Aside from the Indiana site, Novo Nordisk also picked up Catalent plants in Anagni, Italy, and Brussels, Belgium, through the deal.
Indications that the plant had been facing FDA scrutiny emerged in early August, when Regeneron blamed the facility for multiple regulatory hiccups—expected and realized—around Eylea HD and an investigational cancer bispecific.
At the time, Regeneron CEO Len Schleifer, M.D., Ph.D., expressed confidence in Novo’s ability to quickly resolve the issues at the plant, though he cautioned that the Bloomington site produces medicines for the “vast majority of the top biopharmaceutical companies in the world,” noting that he wouldn’t be surprised if other drugs produced there were rejected by the FDA.
Problems at the plant aren’t confined to 2025, either. The FDA flagged similar manufacturing violations during a visit to Bloomington in the fall of 2023, and the situation was much the same when the FDA inspected the site earlier that same year, with the deficiencies found at that time prompting a rejection of Regeneron’s high-dose Eylea.
Production shortfalls at the Bloomington plant were also connected to the delayed release of COVID-19 vaccine boosters from Moderna back in 2022.