As part of the acquisition of manufacturing giant Catalent, Novo Nordisk will fork over $11 billion for three of the CDMO’s plants. But one of those facilities has now been flagged for control lapses.
During an inspection of Catalent’s Bloomington, Indiana, factory last fall, FDA investigators uncovered quality control lapses—and even found a “pest” on the manufacturing line—Reuters first reported Tuesday, citing an agency report obtained via a Freedom of Information Act request.
The FDA’s online records confirm that an inspection focused on drugs and biologics concluded at the Bloomington site on Nov. 15, 2023. At the end of the site review, Catalent was slapped with a voluntary action indicated tag, which means the FDA uncovered manufacturing problems at the plant but stopped short of official regulatory or administrative action.
A Catalent spokesperson confirmed via email that the company received an FDA Form 483 following last year's inspection.
“Catalent takes all regulatory inspections and any resulting observations very seriously," the spokesperson said, noting the company has charted a "comprehensive response" and created "action plans" in light of the FDA's findings. "Catalent continues to pursue its mission of delivering the industry’s most complex manufacturing solutions and innovative medicines for the benefit of our healthcare partners and patients around the world."
While Catalent’s Bloomington site is no stranger to FDA reprimands, this latest write-up is notable given that the site forms part of the $16.5 billion deal Novo Holdings struck to acquire Catalent earlier this week.
As part of the transaction, Novo Nordisk is slated to acquire three of Catalent’s fill-finish sites from its fund manager sibling for $11 billion upfront. The trio of sites specializing in sterile drug filling are located in Italy, Belgium and Bloomington in the U.S. The deal has been pegged to gradually boost Novo Nordisk’s filling capacity from 2026 onward, which will be critical as the Danish drugmaker tries to get on top of supply constraints around its GLP-1 blockbusters Ozempic and Wegovy.
As for Catalent’s specific manufacturing infractions, the FDA made five observations during its review, Reuters reported. For one, Catalent failed to thoroughly review unexplained batch discrepancies for certain products.
Aside from vague and redacted references to a loose “pest” in the plant, the FDA also said some written procedures meant to prevent microbial contamination of sterile products were lacking, citing an instance in which investigators observed operators’ “bare face/skin and gowns touching.”
Certain manufacturing lines were tarnished, too, with the FDA discovering an “apparent brown residue” on one and “ink” on yet another.
Catalent’s Bloomington plant has drawn FDA ire in the past. Last summer, for instance, Regeneron’s high-dose Eylea received a surprising FDA snub that was linked to cleaning and procedural issues at the Indiana plant.
In that case, the FDA’s May 2023 inspection turned up three specific observations related to missed sanitization procedures, equipment issues and inadequate maintenance.