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Form 483
Manufacturing
FDA hit Catalent's Maryland manufacturing sites with Form 483
The observations tied to two April FDA inspections came before Catalent's layoff spree at its Maryland gene therapy manufacturing business.
Zoey Becker
Dec 19, 2025 11:36am
Takeda, Innovent-Lilly, Roche—Fierce Pharma Asia
Oct 31, 2025 8:20am
FDA scolds Hetero over missteps at India warehouse
Oct 28, 2025 10:00am
Novo plant issues may mean delays for Regeneron, Scholar Rock
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