FDA declares Novo Nordisk drug manufacturing plant non-compliant

A troubled contract manufacturing plant in Indiana recently acquired by Novo Nordisk is considered noncompliant with Food and Drug Administration standards, a serious designation that could further delay approval of drugs made at 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 problems, some related to cat hair, pests and equipment failures. Last week, the agency told Novo that the plant was 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 was in contact with the FDA and its manufacturing customers about the new classification. Ensuring the company meets manufacturing standards “is a top priority, and we are improving our processes and procedures as part of our commitment to continuous improvement,” he said.