The U.S. Food and Drug Administration (FDA) has identified repeated quality control failures, including foreign particle contamination, inadequate investigations, and insufficient corrective actions at the Novo Nordisk A/S NVO operated facility in Bloomington, Indiana.

In 2024, Novo Nordisk acquired three fill-finish sites from Novo Holdings A/S for $11 billion. The acquisition was part of a larger deal where Novo Holdings acquired Catalent, Inc. CTLT.

The three sites, located in Anagni, Italy, Brussels, Belgium, and Bloomington, Indiana, specialize in the sterile filling of drugs.

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The company’s internal records revealed multiple deviations involving extrinsic contamination, such as cat hair and unidentified particles found during 100% manual visual inspections.

The problems were reported on Thursday by STAT News, which obtained a copy of the FDA report.

The production plant “failed to determine a root cause of the contamination, assess the potential impact to the rest of the lot, or evaluate whether similar issues may have occurred in upstream batches,” the agency’s investigator wrote.

Hair contamination has been a persistent issue, with at least 20 deviations reported since July 2024.

The company’s deviation investigations often lacked comprehensive historical reviews, limiting searches to one year and failing to consistently include related records such as complaints, CAPAs, and change controls.

The FDA report additionally flagged bacterial contaminations and pest infestations.

For years, the plant also fielded complaints from different clients regarding “foreign matter” detected in lots produced at the facility.

The site also “failed to investigate all critical equipment failures that have the potential to impact drug products,” the agency investigation revealed.

Between late February 2024 and May 2025, the plant opened roughly 10 work orders for “recurrent leaks and/or other failures” of a certain system, for which some repairs were substantially delayed.

In 2022, Catalent received an FDA write-up for its syringe filling facility in Belgium, “allegedly” the culprit behind the supply shortage for Novo Nordisk’s obesity drug Wegovy.

Regulatory concerns extend beyond Novo Nordisk. Regeneron Pharmaceuticals Inc. REGN recently warned that FDA approvals for its EYLEA HD applications, covering pre-filled syringes and expanded dosing schedules, may be pushed back.

The company pointed to FDA observations from a general site inspection at Catalent’s Indiana filler, which is responsible for the EYLEA HD lots tied to those submissions. The applications have Prescription Drug User Fee Act (PDUFA) dates in August 2025.

Price Action: NVO stock is trading lower by 0.32% to $56.80 at last check Monday.

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