FDA Declaration on Novo Nordisk Plant
The FDA has declared a Novo Nordisk plant in Indiana out of compliance, which could delay approval of drugs manufactured at the facility.
A recent FDA inspection found several issues, including problems related to cat hair, pests, and equipment failures.
The plant is classified as “official action required,” a regulatory term meaning the site is in an unacceptable state of compliance.
Novo Nordisk is in contact with the FDA and its manufacturing customers, including Scholar Rock and Regeneron Pharmaceuticals, regarding the new classification.
Author's summary: FDA declares Novo Nordisk plant non-compliant.
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