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.
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.
- The plant is key to drug manufacturing for some biotechs, including Scholar Rock and Regeneron Pharmaceuticals.
- Novo Nordisk is in contact with the FDA and its manufacturing customers about the new classification.
Author's summary: FDA declares Novo Nordisk plant out of compliance.
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