Novo Nordisk, which has stumbled through a bit of a manufacturing hangover at a former Catalent production site it picked up a year ago, was hit with a warning letter from the FDA last month.
The agency’s rebuke—dated Nov. 20 but uploaded on the FDA's website Dec. 11—comes in the wake of Novo receiving a Form 483 in August that resulted from an inspection of the Bloomington, Indiana, facility between June 23 and July 14.
In October, the FDA issued the site its most serious official action indicated label, indicating that it is requiring compliance improvements at the facility. And, earlier this month, one of Novo Nordisk's production clients, Scholar Rock, revealed in a securities filing that the site had received the warning letter.
During the inspection, the FDA found the company failed to properly investigate more than 20 deviations linked to possible contamination of drug product from “mammalian hair” contamination in or around the stopper region of vials. The Form 483 identified the contamination as cat and human hair.
The FDA criticized Novo in the warning letter over its initial investigation and response.
“While we recognize that you worked with your suppliers to reduce the likelihood of mammalian hair contamination events, we are concerned that Novo Nordisk released batches in which your customers found mammalian hair contamination,” the FDA said. “Notably, in a number of instances, your customers ultimately rejected batches after you distributed the batches to them.”
The FDA also noted the company failed to set and follow written procedures to prevent microbiological contamination of sterile products, among other observations.
“We can confirm that we have received a warning letter from the FDA following an inspection of our Bloomington site, and we are actively engaging with the agency to address their findings,” a Novo spokesperson told Fierce in an email.
Novo closed its deal for the plant in December 2024, so some of the issues predate the company's acquisition of the site. In fact, the FDA uncovered similar violations during a 2023 inspection of the Indiana plant. Shortfalls at the site have led to regulatory stumbles for customers that rely on its contract manufacturing capacity, including Regeneron and its high-dose Eylea.
“We recognize that Novo Nordisk is investing significant resources into this facility,” the FDA said in its warning letter. “However, we are concerned that release of potentially contaminated drug products continued to occur well after the Novo Nordisk acquisition.”