FDA Declares Novo Nordisk Plant Out of Compliance
The FDA has declared a Novo Nordisk plant in Indiana out of compliance, which could delay approval of drugs made at the facility.
The plant, recently acquired by Novo Nordisk, was found to have several issues during an FDA inspection, including problems related to cat hair, pests, and equipment failures.
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 Nordisk stated that it is in contact with the FDA and its manufacturing customers about the new classification, which could impact the approval of drugs made by companies such as Scholar Rock and Regeneron Pharmaceuticals.
Author's summary: FDA declares Novo Nordisk plant non-compliant.