FDA slaps Novo Nordisk with warning letter over former Catalent site in Indiana

The U.S. Food and Drug Administration has issued a warning letter to Novo Nordisk regarding a former Catalent site in Bloomington, Indiana — acquired in late 2024 by the Danish drugmaker — which continues to be hit with regulatory actions.

“This warning letter summarizes significant violations of current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals,” the FDA wrote to Novo Nordisk CEO Maziar Doustdar. “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to cGMP, your drug products are adulterated within the meaning of … the Federal Food, Drug, and Cosmetic Act.”

Among the cGMP violations, the agency’s warning letter — dated Nov. 20, 2025 and posted on the FDA’s website last week — called out Novo Nordisk’s inadequate investigations into drug product failures and discrepancies, which “often concluded that no drug product was impacted because finished sterile drug product test results (e.g., sterility, endotoxin, and environmental monitoring) were within specifications.”

A Novo Nordisk spokesperson in an emailed statement to Pharma Manufacturing confirmed that the company received a warning letter from the FDA following an inspection of its Bloomington site and said it is “actively engaging with the agency to address their findings.”

Novo Nordisk bought the troubled Indiana facility — along with two other Catalent sites in Belgium and Italy — in an $11 billion deal completed in December 2024 with parent company Novo Holdings, which acquired the contract manufacturer for $16.5 billion.

In October 2025, the Bloomington plant was hit with the FDA’s most severe post-inspection classification, Official Action Indicated (OAI). According to the agency, an OAI classification indicates a facility is “in an unacceptable state of compliance” and may have been issued a Form FDA-483 or FDA-4056 at the conclusion of an inspection. 

The FDA’s subsequent warning letter was based on the regulator’s inspection of the Bloomington facility from June 23 to July 14, 2025. However, the Indiana site has been plagued for years with regulatory problems going back to Catalent’s ownership of the facility.

In early 2024, Reuters obtained an FDA report in a Freedom of Information Act request, revealing that the Bloomington plant recorded around 194 deviations between Oct. 31, 2021, and Oct 31, 2023, “meaning some aspects of certain batches had failed to meet quality control standards” with Catalent failing to “identify the root cause of 171 of those incidents.”

Regulators in November 2023 found “quality control lapses” at the Indiana factory including discovery of a “pest” on the manufacturing line — though what sort of creature was found and precisely where was not explained in the FDA’s redacted report — according to Reuters.

In the warning letter issued to Novo Nordisk last month, the FDA cited deviations beginning in August 2023 related to “extrinsic mammalian hair” contamination “in or around the stopper region of vials” and “including in direct contact with the drug product” following visual inspection. 

Asked to comment on the FDA’s warning letter to Novo Nordisk, a Catalent spokesperson in an email response said the Bloomington site “has not been a part of Catalent’s network since December 2024, when it was sold to Novo Nordisk.”