Elaine Chen , 2025-10-13 14:35:00
A troubled Indiana contract manufacturing plant recently acquired by Novo Nordisk is considered to not be in compliance with the Food and Drug Administration standards, a serious designation that could further delay the approval of drugs made in the facility, including some from Scholar Rock and Regeneron Pharmaceuticals.
STAT previously reported that an FDA inspection of the plant over the summer found a litany of issues, some related to cat hair, pests, and equipment failures. Last week, the agency told Novo that the plant is classified as “official action required,” a regulatory term meaning the site is in an unacceptable state of compliance, Novo said Monday.
Novo said in a statement that it’s in contact with the FDA and its manufacturing customers about the new classification. Ensuring that the company meets manufacturing standards “is a top priority, and we are enhancing our processes and procedures as part of our commitment to continuous improvement,” it said.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.
Already have an account? Log in
To read the rest of this story subscribe to STAT+.
