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FDA inspection
Manufacturing
Novo plant issues may mean delays for Regeneron, Scholar Rock
The FDA has tagged Novo Nordisk's plant in Indiana with an OAI label, which is the most severe of its three inspection classifications.
Kevin Dunleavy
Oct 13, 2025 3:48pm
J&J subsidiary slapped with FDA warning letter
Sep 23, 2025 2:22pm
Novo plant acquired in Catalent deal lands in FDA's crosshairs
Aug 22, 2025 10:49am
FDA snubs Ultragenyx gene therapy over manufacturing issues
Jul 14, 2025 10:16am
Enhertu, Takeda, Trump—Fierce Pharma Asia
May 9, 2025 6:15am
Trump, in exec order, tasks FDA with boosting US drug production
May 6, 2025 10:18am
