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Form 483
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
Novo plant acquired in Catalent deal lands in FDA's crosshairs
Aug 22, 2025 10:49am
Eli Lilly confirms plan to sell New Jersey plant
Aug 4, 2025 10:50am
China biotech deals, Takeda, LaNova—Fierce Pharma Asia
Jul 18, 2025 9:04am
Trump's tariffs, Leqembi, Kyowa Kirin—Fierce Pharma Asia
Apr 18, 2025 9:25am
Aurobindo discloses FDA Form 483 at North Carolina inhaler plant
Apr 14, 2025 3:00pm
