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.
Novo Nordisk is in contact with the FDA and its manufacturing customers about the new classification, which could impact approval of drugs from companies like Scholar Rock and Regeneron Pharmaceuticals.
Author's summary: FDA declares Novo Nordisk plant out of compliance due to several issues.
- Plant location: Indiana
- Issues found: cat hair, pests, equipment failures
- Affected companies: Scholar Rock, Regeneron Pharmaceuticals
More News
- Fire Country Season 4 Trailer: Who Survives, Who Dies, and What’s Next for Station 42
- Leopards may have feasted on our earliest ancestors
- State rests its case against Donna Adelson without calling son Charlie, defense to call witnesses Tuesday
- ACC Network's Jimbo Fisher: 'I still think I can win the national championship somewhere'
- Are Companies Actually Scaling Back Their Climate Commitments?
- Kissing bugs found in Ohio, experts not concerned
- David Lynch's Estate Up for Auction, Includes Rare Instruments and Gear
- These California Truffle Fries Are So Addictive, You'll Want Them Every Season
- Second explosion strikes Barendrecht home in less than a week
- Power restored to thousands of Hydro One customers in Norfolk County